On March 13, 2023 Eagle Pharmaceuticals, Inc. (Nasdaq: EGRX) ("Eagle" or the "Company") reported financial results for the three and 12 months ended December 31, 2022 (Press release, Eagle Pharmaceuticals, MAR 13, 2023, View Source [SID1234628567]).

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Business and Recent Highlights:

· Received approval from the U.S. Food and Drug Administration ("FDA") for an additional indication for PEMFEXY (pemetrexed injection) in combination with pembrolizumab and platinum chemotherapy for the initial treatment of patients with metastatic, non-squamous, non-small cell lung cancer ("NSCLC") with no EGFR or ALK genomic tumor aberrations. Eagle’s approved PEMFEXY (pemetrexed injection) is a ready-to-dilute ("RTD") novel liquid intravenous formulation developed to eliminate the reconstitution step of the Listed Drug ("LD"), ALIMTA.

o Bought down future royalties on PEMFEXY profits through a one-time payment of $15 million to eliminate the royalty on the first $85 million of profit beginning October 1, 2022, and to reduce the royalty thereafter.

· During the fourth quarter of 2022, the Company reached the contractual limit for royalties paid to development partner on worldwide bendamustine profits.

· Reached a settlement agreement with Accord Healthcare, Inc. ("Accord"). Eagle had asserted its Orange Book-listed patents against Accord related to Accord’s new drug application ("NDA") referencing BENDEKA. The settlement agreement provides that Accord has the right to market its product beginning January 17, 2028, or earlier based on certain circumstances. The settlement agreement is confidential and subject to review by the U.S. Federal Trade Commission and the U.S. Department of Justice.

· FDA accepted the Company’s investigational new drug ("IND") application for CAL02, a novel first-in-class broad-spectrum anti-virulence agent for the adjunct treatment of severe community-acquired bacterial pneumonia ("SCABP"). The Phase 2 study is expected to begin enrollment of approximately 276 patients with severe community-acquired pneumonia at approximately 120 sites worldwide in early 2023.

· With Enalare Therapeutics Inc. ("Enalare"), announced that the FDA granted Orphan Drug Designation ("ODD") for the treatment of Apnea of Prematurity ("AoP") to ENA-001, a new chemical entity with a novel mechanism of action as a respiratory stimulant. Enalare’s lead compound, ENA-001 is an investigational, one-of-a-kind NCE being developed as an agnostic respiratory stimulant for multiple patient populations experiencing acute respiratory depression. In August 2022, Eagle acquired a 17% equity stake in Enalare, with an option to purchase the remaining shares of Enalare upon achievement of specified milestones, presenting the potential to add to Eagle’s portfolio novel NCEs with strong intellectual property protection, from the mid-2030s into the 2040s, including composition of matter patents.

· Hosted Investor Day including in-depth discussions of pipeline products, newly acquired acute care products, and perspectives from Key Opinion Leaders in each clinical area

Financial Highlights

Fourth Quarter 2022

· Total revenue for Q4 2022 was $60.7 million, compared to $42.3 million in Q4 2021.

· Q4 2022 net income was $8.2 million, or $0.63 per basic and $0.62 per diluted share, compared to net loss of $(6.2) million, or $(0.48) per basic and diluted share, in Q4 2021.

· Q4 2022 adjusted non-GAAP net income was $14.4 million, or $1.11 per basic and $1.10 per diluted share, compared to adjusted non-GAAP net income of $11.0 million, or $0.85 per basic and $0.83 per diluted share, in Q4 2021. 1

· Cash and cash equivalents were $55.3 million, net accounts receivable was $72.4 million, and total debt was $63.8 million, as of December 31, 2022.

Full Year 2022

· Total revenue for the 12 months ended December 31, 2022 was $316.6 million, compared to $171.5 million, in 2021, an increase of 84.6%.

· Net income for the 12 months ended December 31, 2022 was $35.6 million, or $2.76 per basic and $2.73 per diluted share, compared to net loss of $(8.6) million, or $(0.66) per basic and diluted share, in 2021.

· Adjusted non-GAAP net income for the 12 months ended December 31, 2022 was $101.8 million, or $7.87 per basic and $7.79 per diluted share, compared to $22.3 million, or $1.71 per basic and $1.68 per diluted share, in 2021.1

· From August 2016 through December 31, 2022, Eagle has repurchased $246.1 million of its common stock through its Share Repurchase Program.

"2022 was an outstanding year for Eagle, as we tripled our adjusted non-GAAP net income per diluted share over 2021. This is a significant achievement for a company of our size, and I am pleased that we accomplished this almost entirely through organic growth. During the final three months of 2022, we recorded $12 million of Pemfexy net sales and exited the quarter with a 6% U.S. market share in community oncology. We anticipate doubling this share to approximately 12% leaving the first quarter of 2023, and have already captured a 10% share through February2," stated Scott Tarriff, President and Chief Executive Officer of Eagle Pharmaceuticals.

"Looking ahead, we anticipate growth in Barhemsys and Byfavo over time now that our sales force is scaled to plan and trained. We intend to continue to manage our U.S. bendamustine franchise, support Enalare’s development of ENA-001, and advance our pipeline programs for CAL02 and landiolol. We believe our strong cash position and balance sheet provide us with the flexibility not only to support our clinical development work but also to seek a meaningful acquisition that could potentially go a long way in solidifying Eagle’s position as a diversified pharmaceutical company," concluded Tarriff

Fourth Quarter 2022 Financial Results

Total revenue for the three months ended December 31, 2022 was $60.7 million, as compared to $42.3 million for the three months ended December 31, 2021.

Q4 2022 RYANODEX net product sales were $7.2 million, compared to $6.1 million in the fourth quarter of 2021.

Q4 2022 BELRAPZO net product sales were $11.0 million, compared to $5.5 million in the fourth quarter of 2021.

Q4 2022 PEMFEXY net product sales were $12.1 million and vasopressin net product sales were $3.6 million.

A summary of total revenue is outlined below:

Three Months Ended December 31,
2022 2021
(unaudited) (unaudited)
Revenue (in thousands):
Product sales, net $ 37,161 $ 16,158
Royalty revenue 23,538 26,162
Total revenue $ 60,699 $ 42,320

Q4 2022 royalty revenue was $23.5 million, compared to $26.2 million in the prior year quarter. Full-year 2022 royalty revenue totaled $98.3 million compared to $106.5 million in 2021.

During the first quarter of 2023, Eagle provided notice to customers and the FDA that the Company is withdrawing from the vasopressin market; inventory is expected to be depleted by the end of the second quarter of 2023.

Gross margin was 67% during the fourth quarter of 2022, compared to 71% in the fourth quarter of 2021. The decrease in gross margin was driven by a change in the revenue mix, including the launch of PEMFEXY and vasopressin and amortization expense related to PEMFEXY, BARHEMSYS and BYFAVO.

R&D expense was $7.2 million for the fourth quarter of 2022, compared to $3.8 million for the fourth quarter of 2021. The increase was primarily due to higher spend of $3.9 million on CAL02.

SG&A expenses in the fourth quarter of 2022 totaled $24.2 million, compared to $20.3 million in the fourth quarter of 2021. This increase was primarily related to increased sales and marketing expense including headcount costs of $1.7 million and marketing costs of 2.1 million associated with BARHEMSYS, BYFAVO and PEMFEXY.

Net income for the fourth quarter of 2022 was $8.2 million, or $0.63 per basic and $0.62 per diluted share, compared to net loss of $(6.2) million, or $(0.48) per basic and diluted share, in the fourth quarter of 2021, primarily as a result of the factors discussed above

Adjusted non-GAAP net income for the fourth quarter of 2022 was $14.4 million, or $1.11 per basic and $1.10 per diluted share, compared to adjusted non-GAAP net income1 of $11.0 million, or $0.85 per basic and $0.83 per diluted share, in the fourth quarter of 2021.

Full Year 2022 Financial Results

Total revenue for the year ended December 31, 2022 was $316.6 million, as compared to $171.5 million for the year ended December 31, 2021. A summary of total revenue is outlined below:

Twelve Months Ended December 31,
2022 2021
Revenue (in thousands):
Product sales, net $ 214,536 $ 65,023
Royalty revenue 98,266 106,523
License and other revenue 3,808 —
Total revenue $ 316,610 $ 171,546

Net revenues increased by $145.1 million to $316.6 million in the year ended December 31, 2022 compared to $171.5 million in 2021, primarily driven by the launches of PEMFEXY and vasopressin, increases in product sales of BELRAPZO of $9.9 million and Ryanodex of $4.9 million, the acquisition of BARHEMSYS and BYFAVO, and increases in TREAKISYM royalties of $4.1 million, partially offset by a decrease in royalties of BENDEKA of $12.3 million. During 2022, we recorded $3.8 million of other revenue for a cumulative sales milestone on sales of TREAKISYM in Japan by our marketing partner, SymBio.

Gross margin was 70% for the full year 2022, as compared to 75% for 2021. The decrease in gross margin was driven by a change in the revenue mix, including the launch of PEMFEXY and vasopressin and amortization expense related to PEMFEXY, BARHEMSYS and BYFAVO.

R&D expense decreased to $34.1 million in 2022, compared to $51.3 million in 2021, primarily reflecting the non-recurrence of a $10.0 million upfront payment related to our license agreement with Combioxin SA for CAL02, a $5.0 million upfront payment related to our licensing agreement with AOP Orphan for landiolol, lower headcount cost of $1.3 million, lower spend of vasopressin of $7.6 million, RYANODEX and EA111 of $3.1 million and PEMFEXY of $2.2 million. This was partially offset by $11.0 million of CMC and clinical expenses on our CAL02 program.

Excluding stock-based compensation and other non-cash items, adjusted non-GAAP R&D expense1 for 2022 was $31.5 million.

SG&A expenses increased by $31.3 million to $106.6 million in 2022, compared to $75.3 million in 2021. The increase primarily reflects $16.6 million of higher professional fees which primarily resulted from our Acacia Pharma Group plc ("Acacia") and Enalare transactions, $6.9 million of severance related to the acquisition of Acacia, and increased sales and marketing expense which includes increased headcount costs of $3.8 million and increased marketing costs of 5.9 million associated with BARHEMSYS, BYFAVO and PEMFEXY. This was partially offset by $2.9 million of lower stock-based compensation expense

Net income for the year ended December 31, 2022 was $35.6 million, or $2.76 per basic and $2.73 per diluted share, as compared to net loss of $(8.6) million or $(0.66) per basic and diluted share for the year ended December 31, 2021, as a result of the factors discussed above.

Adjusted non-GAAP net income for the year ended December 31, 2022 was $101.8 million, or $7.87 per basic and $7.79 per diluted share, compared to adjusted non-GAAP net income1 of $22.3 million, or $1.71 per basic and $1.68 per diluted share, for 2021.1

2023 Guidance

· Adjusted EBITDA of $74.0-$80.0 million1

· Adjusted non-GAAP earnings per share of $4.20-$4.531

· Adjusted non-GAAP R&D expense of $41.0-$45.0 million1

· Adjusted non-GAAP SG&A expense of $86.0-$90.0 million1

Liquidity

As of December 31, 2022, Eagle had $55.3 million in cash and cash equivalents, $72.4 million in accounts receivable, net, and $63.8 million in outstanding debt on the Company’s $150 million credit facility with JPMorgan. Therefore, as of December 31, 2022, Eagle had cash and cash equivalents plus accounts receivables, net of $127.7 million.

In 2022, Eagle repurchased $18.0 million of its common stock as part of its Share Repurchase Program. From August 2016 through December 31, 2022, Eagle has repurchased $246.1 million of its common stock.

Conference Call

As previously announced, Eagle management will host its fourth quarter 2022 conference call as follows:

Date March 13, 2023

Time 8:30 A.M. ET

Toll free (U.S.) 800-445-7795

International 785-424-1789

Webcast (live and replay) www.eagleus.com, under the "Investor + News" section

A replay of the conference call will be available for two weeks after the call’s completion by dialing 800-839-4199 (U.S.) or 402-220-2989 (International) and entering conference call ID EGRXQ422. The webcast will be archived for 30 days at the aforementioned URL.

On March 13, 2023 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported its financial results for the full year and fourth quarter 2022 on Monday, March 27th, 2023 (Press release, BioNTech, MAR 13, 2023, View Source [SID1234628565]). BioNTech invites investors and the general public to join a conference call and webcast with investment analysts on the same day at 8.00 a.m. EDT (2.00 p.m. CEST) to report its financial results and provide a corporate update for the fourth quarter and full year 2022.

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To access the live conference call via telephone, please register via this link. Once registered, dial-in numbers and a pin will be provided. It is recommended to register at least a day in advance.

The slide presentation and audio of the webcast will be available via this link.

Participants may also access the slides and the webcast of the conference call via the "Events & Presentations" page of the Investor Relations section of the Company’s website at www.BioNTech.com. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On March 13, 2023 Alpha Tau Medical Ltd. ("Alpha Tau", or the "Company") (NASDAQ: DRTS, DRTSW), the developer of the innovative alpha-radiation cancer therapy Alpha DaRT, reported the following statement on Silicon Valley Bank (SVB) in response to questions from investors and analysts (Press release, Alpha Tau Medical, MAR 13, 2023, View Source [SID1234628564]).

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We maintain no accounts or other financial relationships with SVB, and we do not currently expect its closure to have any impact on our operations.

On March 13, 2023 AbbVie (NYSE: ABBV) reported it will present more than 20 abstracts, including one late-breaking presentation during the 2023 American Academy of Dermatology (AAD) Annual Meeting, March 17-21, in New Orleans, Louisiana (Press release, AbbVie, MAR 13, 2023, View Source [SID1234628562]).

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"The data at this year’s AAD conference demonstrate AbbVie’s commitment to investing in its dermatology portfolio to further improve outcomes for patients with immune-mediated skin conditions," said Celine Goldberger, M.D., vice president, head of U.S. medical affairs, AbbVie. "We look forward to sharing new evidence that further builds upon AbbVie’s strong scientific foundation and helps to elevate the standards of care for patients."

The oral and poster presentations from AbbVie highlight research across the company’s collective portfolio, further demonstrating leadership in dermatology innovation. Data feature outcomes in psoriatic disease, atopic dermatitis and hidradenitis suppurativa to support patients living with immune-mediated skin conditions. Notable data presentations will include:

A late-breaking oral presentation and several poster abstracts assessing the efficacy, durability, and safety of risankizumab in patients with moderate to severe plaque psoriasis, including follow-up of over 256 weeks in patients with prior biologic treatment, as well as abstracts assessing long-term outcomes of risankizumab in patients with active psoriatic arthritis.
Subgroup analyses of outcomes, including skin clearance (EASI 75, vIGA 0/1) and patient-reported outcomes (pruritis, skin symptoms, sleep and quality of life), in adults and adolescents with atopic dermatitis from three Phase 3 trials assessing the efficacy and safety of upadacitinib across 52 weeks.
A Phase 2 study evaluating the efficacy and safety of upadacitinib in moderate-to-severe hidradenitis suppurativa.
Select AbbVie abstracts at AAD 2023 are outlined below. The 2023 AAD Annual Meeting e-Posters are available here and late-breaking sessions are available here.

Abstract Title

Presentation Details
(All Times CT)

Psoriasis

Efficacy and Safety in Psoriasis Patients Switching to Risankizumab After
Suboptimal Response to Secukinumab or Ixekizumab After 52 Weeks

Late-Breaking Oral Presentation;

Theater B;
March 18, 2023

11:40-11:50 a.m.

Long-Term Safety and Efficacy of Risankizumab for the Treatment of Moderate-to-
Severe Plaque Psoriasis: Interim Analysis of Results from the LIMMitless Open-
Label Extension Trial Up to Five Years of Follow-Up

Poster #43928;
Poster Center 2:

Poster with Oral;

March 19, 2023
1:25-1:30 p.m.

Long-Term Real-World Treat-to-Target Skin Clearance and Maintenance of
Response with Risankizumab in Patients with Moderate to Severe Psoriasis from
the CorEvitas Psoriasis Registry

Poster #44047

Poster Center 2

Poster with Oral;

March 19, 2023

1:30-1:35 p.m.

Risankizumab Efficacy for Moderate-to-Severe Plaque Psoriasis Over 256 Weeks
in Patients with Prior Biologic Treatments

Poster #44102;

Poster Center 2;
Poster with Oral;
March 19, 2023
1:40-1:45 p.m.

Real-World Switch Rates of Biologics and Associated Costs in Patients with
Psoriasis

Poster #41279;

Poster Center 2;

Poster with Oral;
March 19, 2023
1:45-1:50 p.m.

Long-Term Efficacy of Continuous Risankizumab in Psoriasis by Body Region: An
Updated Integrated Analysis from the LIMMitless Open-Label Extension Study

Poster #44022;

E-poster

Long-Term Improvement in Difficult-To-Treat Areas and Quality of Life in Patients
with Psoriasis Up to 204 Weeks Post Switch from Ustekinumab To Risankizumab

Poster #44134;

E-poster

Psoriatic Arthritis

Impact of Risankizumab on Nail Psoriasis and Enthesitis Among Psoriatic Arthritis
Patients with High Nail Symptom Burden

Poster #44094

Poster Center 2

Poster with Oral;

March 19, 2023

1:35-1:40 p.m.

Improvements in Patient-Reported Outcomes Among Patients with Resolution of
Enthesitis and/or Dactylitis: Post Hoc Analyses from the KEEPsAKE 1 and 2 Trials
of Risankizumab in Patients with Active Psoriatic Arthritis

Poster #42267;

Poster Center 2;

Poster with Oral;

March 19, 2023
2:05-2:10 p.m.

Improvements in Manifestations of Active Psoriatic Arthritis with Risankizumab
Treatment After Intolerance or Inadequate Response to Prior Biologic Therapy:
Subgroup Analyses from the KEEPsAKE 2 Trial

Poster #43944;

E-poster

Atopic Dermatitis

Sustained Improvement Over 52 Weeks in Patient-Reported Itch, Symptoms, and
Quality of Life with Upadacitinib in Patients with Atopic Dermatitis: Results from
Phase 3 Studies (Measure Up 1, Measure Up 2, and AD Up)

Poster #42262;

Poster Center 2;

Poster with Oral;
March 17, 2023
1:40-1:45 p.m.

Improvement in Itch, Symptoms and Quality of Life with Upadacitinib Through
Week 16 in Adults and Adolescents with Atopic Dermatitis: results from Phase 3
Studies (Measure Up 1, Measure Up 2 and AD Up)

Poster #42065

E-poster

Efficacy and Safety of Upadacitinib in Adults and Adolescents with Moderate-to-
Severe Atopic Dermatitis: Subgroup Analysis of the Measure Up 1, Measure Up 2
and AD Up Phase 3 Clinical Trials at 52 Weeks

Poster #43049;

E-poster

Hidradenitis Suppurativa

Efficacy and Safety of Upadacitinib in Moderate-to-Severe Hidradenitis
Suppurativa: A Phase 2, Randomized, Placebo-Controlled Study

Poster #43799;

Poster Center 2;

Poster with Oral;
March 19, 2023
1:25-1:30 p.m.

SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization of SKYRIZI globally.

About SKYRIZI (risankizumab-rzaa)
SKYRIZI is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit.1 IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases, including psoriasis.1 Phase 3 trials of SKYRIZI in psoriasis, Crohn’s disease, ulcerative colitis and psoriatic arthritis are ongoing.2-7

SKYRIZI U.S. Uses and Important Safety Information8

SKYRIZI is a prescription medicine used to treat adults with:

moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).
active psoriatic arthritis (PsA).
moderate to severe Crohn’s disease.
IMPORTANT SAFETY INFORMATION

What is the most important information I should know about SKYRIZI (risankizumab-rzaa)?

SKYRIZI is a prescription medicine that may cause serious side effects, including:

Serious allergic reactions:

Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction:
– fainting, dizziness, feeling lightheaded (low blood pressure)
– swelling of your face, eyelids, lips, mouth, tongue, or throat
– trouble breathing or throat tightness
– chest tightness
– skin rash, hives
– itching

Infections:

SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI.

Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including:
– fever, sweats, or chills
– cough
– shortness of breath
– blood in your mucus (phlegm)
– muscle aches
– warm, red, or painful skin or sores on your body different from your psoriasis
– weight loss
– diarrhea or stomach pain
– burning when you urinate or urinating more often than normal

Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

Before using SKYRIZI, tell your healthcare provider about all of your medical conditions,
including if you:

have any of the conditions or symptoms listed in the section "What is the most important information I should know about SKYRIZI?"
have an infection that does not go away or that keeps coming back.
have TB or have been in close contact with someone with TB.
have recently received or are scheduled to receive an immunization (vaccine). Medicines that interact with the immune system may increase your risk of getting an infection after receiving live vaccines. You should avoid receiving live vaccines right before, during, or right after treatment with SKYRIZI. Tell your healthcare provider that you are taking SKYRIZI before receiving a vaccine.
are pregnant or plan to become pregnant. It is not known if SKYRIZI can harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if SKYRIZI passes into your breast milk.
become pregnant while taking SKYRIZI. You are encouraged to enroll in the Pregnancy Registry, which is used to collect information about the health of you and your baby. Talk to your healthcare provider or call 1-877-302-2161 to enroll in this registry.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of SKYRIZI?

SKYRIZI may cause serious side effects. See "What is the most important information I should know about SKYRIZI?"

Liver problems in Crohn’s disease: A person with Crohn’s disease who received SKYRIZI through a vein in the arm developed changes in liver blood tests with a rash that led to hospitalization. Your healthcare provider will do blood tests to check your liver before, during, and up to 12 weeks of treatment and may stop treatment with SKYRIZI if you develop liver problems. Tell your healthcare provider right away if you notice any of the following symptoms: unexplained rash, nausea, vomiting, stomach (abdominal) pain, tiredness (fatigue), loss of appetite, yellowing of the skin and eyes (jaundice), and dark urine.

The most common side effects of SKYRIZI in people treated for Crohn’s disease include: upper respiratory infections, headache, joint pain, stomach (abdominal) pain, injection site reactions, low red blood cells (anemia), fever, back pain, and urinary tract infection.

The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: upper respiratory infections, headache, feeling tired, injection site reactions, and fungal skin infections.

These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about
side effects.

Use SKYRIZI exactly as your healthcare provider tells you to use it.

SKYRIZI is available in a 150 mg/mL prefilled syringe and pen, a 600 mg/10 mL vial for intravenous infusion, and a 180 mg/1.2 mL or 360 mg/2.4 mL single-dose prefilled cartridge with on-body injector.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click here for Full Prescribing Information and Medication Guide for SKYRIZI.

Globally, prescribing information varies; refer to the individual country product label for complete information.

About RINVOQ (upadacitinib)
Discovered and developed by AbbVie scientists, RINVOQ is a selective JAK inhibitor that is being studied in several immune-mediated inflammatory diseases.9 Based on enzymatic and cellular assays, RINVOQ demonstrated greater inhibitory potency for JAK-1 vs JAK-2, JAK-3, and TYK-2.10 The relevance of inhibition of specific JAK enzymes to therapeutic effectiveness and safety is not currently known.

The use of upadacitinib in hidradenitis suppurativa is not approved and its safety and efficacy have not been established by global regulatory authorities. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn’s disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.11-18

RINVOQ (upadacitinib) U.S. Use and Important Safety Information10

USES

RINVOQ is a prescription medicine used to treat:

Adults with moderate to severe rheumatoid arthritis (RA) when 1 or more medicines called tumor necrosis factor (TNF) blockers have been used, and did not work well or could not be tolerated.
Adults with active psoriatic arthritis (PsA) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
Adults with moderate to severe ulcerative colitis (UC) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
Adults with active ankylosing spondylitis (AS) when 1 or more medicines called TNF blockers have been used, and did not work well or could not be tolerated.
Adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation when a TNF blocker medicine has been used, and did not work well or could not be tolerated.
It is not known if RINVOQ is safe and effective in children with juvenile idiopathic arthritis, psoriatic arthritis, ulcerative colitis, ankylosing spondylitis, or non-radiographic axial spondyloarthritis.

Adults and children 12 years of age and older with moderate to severe eczema (atopic dermatitis [AD]) that did not respond to previous treatment and their eczema is not well controlled with other pills or injections, including biologic medicines, or the use of other pills or injections is not recommended.
RINVOQ is safe and effective in children 12 years of age and older weighing at least 88 pounds (40 kg) with atopic dermatitis.

It is not known if RINVOQ is safe and effective in children under 12 years of age with atopic dermatitis.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about RINVOQ?

RINVOQ may cause serious side effects, including:

Serious infections. RINVOQ can lower your ability to fight infections. Serious infections have happened while taking RINVOQ, including tuberculosis (TB) and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Your healthcare provider (HCP) should test you for TB before starting RINVOQ and check you closely for signs and symptoms of TB during treatment with RINVOQ. You should not start taking RINVOQ if you have any kind of infection unless your HCP tells you it is okay. If you get a serious infection, your HCP may stop your treatment until your infection is controlled. You may be at higher risk of developing shingles (herpes zoster).
Increased risk of death in people 50 years and older who have at least 1 heart disease (cardiovascular) risk factor.
Cancer and immune system problems. RINVOQ may increase your risk of certain cancers. Lymphoma and other cancers, including skin cancers, can happen. Current or past smokers are at higher risk of certain cancers, including lymphoma and lung cancer. Follow your HCP’s advice about having your skin checked for skin cancer during treatment with RINVOQ. Limit the amount of time you spend in sunlight. Wear protective clothing when you are in the sun and use sunscreen.
Increased risk of major cardiovascular (CV) events, such as heart attack, stroke, or death, in people 50 years and older who have at least 1 heart disease (CV) risk factor, especially if you are a current or past smoker.
Blood clots. Blood clots in the veins of the legs or lungs and arteries can happen with RINVOQ. This may be life-threatening and cause death. Blood clots in the veins of the legs and lungs have happened more often in people who are 50 years and older and with at least 1 heart disease (CV) risk factor.
Allergic reactions. Symptoms such as rash (hives), trouble breathing, feeling faint or dizzy, or swelling of your lips, tongue, or throat, that may mean you are having an allergic reaction have been seen in people taking RINVOQ. Some of these reactions were serious. If any of these symptoms occur during treatment with RINVOQ, stop taking RINVOQ and get emergency medical help right away.
Tears in the stomach or intestines and changes in certain laboratory tests. Your HCP should do blood tests before you start taking RINVOQ and while you take it. Your HCP may stop your RINVOQ treatment for a period of time if needed because of changes in these blood test results.
Do not take RINVOQ if you are allergic to upadacitinib or any of the ingredients in RINVOQ. See the Medication Guide or Consumer Brief Summary for a complete list of ingredients.

What should I tell my HCP BEFORE starting RINVOQ?

Tell your HCP if you:

Are being treated for an infection, have an infection that won’t go away or keeps coming back, or have symptoms of an infection, such as

Fever, sweating, or chills

– Shortness of breath

– Warm, red, or painful skin or sores on your body

– Muscle aches

– Feeling tired

– Blood in phlegm

– Diarrhea or stomach pain

– Cough

– Weight loss

– Burning when urinating or urinating more often than normal

Have TB or have been in close contact with someone with TB.
Are a current or past smoker.
Have had a heart attack, other heart problems, or stroke.
Have or have had any type of cancer, hepatitis B or C, shingles (herpes zoster), blood clots in the veins of your legs or lungs, diverticulitis (inflammation in parts of the large intestine), or ulcers in your stomach or intestines.
Have other medical conditions, including liver problems, low blood cell counts, diabetes, chronic lung disease, HIV, or a weak immune system.
Live, have lived, or have traveled to parts of the country, such as the Ohio and Mississippi River valleys and the Southwest, that increase your risk of getting certain kinds of fungal infections. If you are unsure if you’ve been to these types of areas, ask your HCP.
Have recently received or are scheduled to receive a vaccine. People who take RINVOQ should not receive live vaccines.
Are pregnant or plan to become pregnant. Based on animal studies, RINVOQ may harm your unborn baby. Your HCP will check whether or not you are pregnant before you start RINVOQ. You should use effective birth control (contraception) to avoid becoming pregnant during treatment with RINVOQ and for 4 weeks after your last dose.
Are breastfeeding or plan to breastfeed. RINVOQ may pass into your breast milk. Do not breastfeed during treatment with RINVOQ and for 6 days after your last dose.
Tell your HCP about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. RINVOQ and other medicines may affect each other, causing side effects.

Especially tell your HCP if you take:

Medicines for fungal or bacterial infections
Rifampicin or phenytoin
Medicines that affect your immune system
If you are not sure if you are taking any of these medicines, ask your HCP or pharmacist.

What should I avoid while taking RINVOQ?

Avoid food or drink containing grapefruit during treatment with RINVOQ as it may increase the risk of side effects.

What should I do or tell my HCP AFTER starting RINVOQ?

Tell your HCP right away if you have any symptoms of an infection. RINVOQ can make you more likely to get infections or make any infections you have worse.
Get emergency help right away if you have any symptoms of a heart attack or stroke while taking RINVOQ, including:
– Discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back
– Severe tightness, pain, pressure, or heaviness in your chest, throat, neck, or jaw
– Pain or discomfort in your arms, back, neck, jaw, or stomach
– Shortness of breath with or without chest discomfort
– Breaking out in a cold sweat
– Nausea or vomiting
– Feeling lightheaded
– Weakness in one part or on one side of your body
– Slurred speech

Tell your HCP right away if you have any signs or symptoms of blood clots during treatment with RINVOQ, including

Swelling

– Pain or tenderness in one or both legs

– Sudden unexplained chest or upper back pain

– Shortness of breath or difficulty breathing

Tell your HCP right away if you have a fever or stomach-area pain that does not go away, and a change in your bowel habits.
What are other possible side effects of RINVOQ?

Common side effects include upper respiratory tract infections (common cold, sinus infections), shingles (herpes zoster), herpes simplex virus infections (including cold sores), bronchitis, nausea, cough, fever, acne, headache, increased blood levels of creatine phosphokinase, allergic reactions, inflammation of hair follicles, stomach-area (abdominal) pain, increased weight, flu, tiredness, lower number of certain types of white blood cells (neutropenia, lymphopenia), muscle pain, flu-like illness, rash, increased blood cholesterol levels, and increased liver enzyme levels.

A separation or tear to the lining of the back part of the eye (retinal detachment) has happened in people with atopic dermatitis treated with RINVOQ. Call your HCP right away if you have any sudden changes in your vision during treatment with RINVOQ.

These are not all the possible side effects of RINVOQ.

How should I take RINVOQ?

RINVOQ is taken once a day with or without food. Do not split, crush, or chew the tablet. Take RINVOQ exactly as your HCP tells you to use it. RINVOQ is available in 15 mg, 30 mg, and 45 mg extended-release tablets.

This is the most important information to know about RINVOQ. For more information, talk to your HCP.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

Please click here for the Full Prescribing Information and Medication Guide for RINVOQ.

Globally, prescribing information varies; refer to the individual country product label for complete information.

On March 13, 2023 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that Silicon Valley Bank has been closed by the California Department of Financial Protection and Innovation, which appointed the Federal Deposit Insurance Corporation ("FDIC") as receiver (Press release, Innate Pharma, MAR 13, 2023, View Source [SID1234628551]).

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None of Innate Pharma’s cash and cash equivalents are held through Silicon Valley Bank and none of its investment portfolio has exposure to Silicon Valley Bank.

In May 2022, Innate Pharma established an At-The-Market (ATM) program (for which the outstanding balance remains at $75m) with SVB Securities. The Company understand that SVB Securities is owned by SVB Financial Group, the parent of Silicon Valley Bank. SVB Securities has published a press release on March 11, 2023 stating that it "continues its independent operations unimpeded by Silicon Valley Bank’s receivership proceedings."

Innate Pharma therefore does not see any impact to its liquidity position or its ongoing operations as a result of this event.