Life Science News

$21.6 million in net revenue for Q1 2022; Maintains net revenue guidance range of $115-$135 million from sales of LUPKYNIS for 2022

Continued increases in LUPKYNIS™ (voclosporin) Patients on Treatment and Patient Start Forms; Steady Conversion Rates and Payor Coverage

EMA review of LUPKYNIS remains on track with decision expected in 2H 2022

Conference call to be hosted today at 8:30 a.m. ET

Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) (Aurinia or the Company) today issued its financial results for the first quarter ended March 31, 2022. Amounts, unless specified otherwise, are expressed in U.S. dollars.

Net product revenues were $21.6 million for the quarter ended March 31, 2022, compared to $914 thousand in the prior year period, reflecting FDA approval of LUPKYNIS in late January 2021.

"As previously reported on our fourth quarter call, LUPKYNIS revenues in the first quarter were impacted by care disruptions to both patients and the healthcare system caused by the COVID-19 Omicron variant. We are quite pleased that exiting the quarter, as Omicron abated, we began to see a significant increase in prescribing, patient starts, and refills, leading to a monthly record for received patient start forms and patient starts in March," said Peter Greenleaf, President and Chief Executive Officer of Aurinia. "Heading into the second half of the year, in addition to expected growth in LUPKYNIS revenues, we look forward to multiple expected corporate milestones, including potential European LUPKYNIS approval, the presentation of additional clinical data sets and continued development progress with our pipeline products, AUR200 and AUR300."

For fiscal year 2022, the Company maintains its net revenue guidance of $115 million to $135 million from sales of LUPKYNIS. This range is based on assumptions regarding the impact of COVID-19 on the current business environment and represents an increase of more than 150 to 200% in net revenue from sales of LUPKYNIS compared to fiscal year 2021. Aurinia's guidance does not include any potential milestone payments, royalties or contract manufacturing revenue related to the Company's licensing agreement with Otsuka Pharmaceutical or associated with the marketing of voclosporin in the European Union or Japan.

First Quarter 2022 and Recent Highlights & Upcoming Milestones:

  • Aurinia added 461 patient start forms (PSFs) during the first quarter 2022, as compared to 257 in the first quarter 2021.
  • As of Friday, May 6, 2022, the Company recorded 647 total PSFs since January 1, 2022.
  • PSF conversion rates are now at 80% after 90 days; confirmed patient access to LUPKYNIS through payors and plans remains steady representing about 90% of U.S. total lives.
  • There were approximately 1,071 patients on LUPKYNIS therapy at March 31, 2022, compared with 884 at the end of 2021. At 6 months post-treatment-start, an average of approximately 70% of patients remain on treatment.
  • Per recent healthcare provider (HCP) surveys, unaided brand awareness of LUPKYNIS is over 70% while aided brand awareness is over 90% and intent to use in the next 3 months is over 70%, the highest level since launch.
  • The first presentations of final AURORA 2 continuation study data are expected at the 59th European Renal Association (ERA) Congress and at the European Congress of Rheumatology at the end of May, 2022 and at the European Alliance of Associations for Rheumatology (EULAR) 2022 in June. Submission of a manuscript with the full results is expected in the second half of 2022.
  • With the start of the year, the Aurinia commercial team initiated several new HCP and patient-targeted marketing programs that include the AURORA 2 data and patient brand ambassadors.
  • Regulatory review of the European Medicines Agency (EMA) marketing authorization application (MAA) remains on track with a European Commission (EC) approval decision expected in second half of 2022.
  • Recruitment of patients and initiation of new sites into both the VOCAL pediatric study and the ENLIGHT-LN registry is continuing.

Financial Liquidity at March 31, 2022

As of March 31, 2022, Aurinia had cash, cash equivalents and restricted cash and investments of $418.8 million compared to $466.1 million at December 31, 2021. The decrease in cash, cash equivalents and restricted cash and investments is primarily related to the continued investment in commercialization activities, payments made for our ongoing post approval obligations and advancement of our pipeline, payments associated with inventory purchases to ensure adequate supply to meet forecasted demand and a payment for the achievement of a one-time milestone, partially offset by an increase in cash receipts from sales of LUPKYNIS.

Aurinia believes that it has sufficient financial resources to fund its current operations, which include funding commercial activities, including FDA related post approval commitments, manufacturing and packaging of commercial drug supply, funding its supporting commercial infrastructure, conducting planned research and development (R&D) programs, investing in its pipeline and operating activities for at least the next few years.

Financial Results for the Quarter Ended March 31, 2022

Total net revenue was $21.6 million and $914 thousand for the quarters ended March 31, 2022 and March 31, 2021, respectively. Net revenues primarily consisted of product revenue, net of adjustments for LUPKYNIS, following FDA approval in late January 2021. Quarter over quarter revenue growth is attributed to continued progress in the launch of LUPKYNIS, driven predominantly by further penetration into the LN market.

Total cost of sales and operating expenses for the quarter ended March 31, 2022 were $59.5 million in comparison to $51.5 million for the quarter ended March 31, 2021.

Cost of sales were $256 thousand and $48 thousand for the quarters ended March 31, 2022 and March 31, 2021, respectively. The increase was primarily due to the growth of LUPKYNIS sales, in comparison to the prior year period.

Gross margin for the quarters ended March 31, 2022 and March 31, 2021 was approximately 99% and 95% respectively. The fluctuation in gross margin is driven primarily by fixed specialty pharmacy costs in the first quarter of 2021, as a larger percentage of the overall cost of sales in the quarter.

Selling, general and administrative (SG&A) expenses were $45.2 million and $39.8 million for the quarters ended March 31, 2022 and March 31, 2021, respectively, which is consistent with the prior quarter and represents a fully burdened quarter, as the Company did not have approval until late January 2021. The increase was primarily due to an increase in employee related expenses, professional fees related to various corporate matters, pharmacovigilance costs and consulting related expenses tied to the increased investment in back office infrastructure to support the commercialization of LUPKYNIS.

Non-cash SG&A share-based compensation expense for the quarters ended March 31, 2022 and March 31, 2021 was $6.0 million and $6.6 million, respectively.

R&D expenses were $12.6 million and $9.8 million for the quarters ended March 31, 2022 and March 31, 2021, respectively. The primary driver for the increase quarter over quarter was due to an increase in expenses related to AUR200 and AUR300 development, partially offset by a decrease in expenses related to the AURORA 2 continuation study which was completed during the fourth quarter of 2021 but had wind down activities ongoing in the quarter ended March 31, 2022.

Non-cash R&D share-based compensation expense for the quarters ended March 31, 2022 and March 31, 2021 was $1.0 million compared to $1.1 million, respectively.

For the quarter ended March 31, 2022, Aurinia recorded a net loss of $37.6 million or $0.27 net loss per common share, as compared to a net loss of $50.4 million or $0.40 net loss per common share for the quarter ended March 31, 2021.

This press release is intended to be read in conjunction with the Company's unaudited condensed consolidated financial statements and Management's Discussion and Analysis for the quarter ended March 31, 2022 in the Company's Quarterly Report on Form 10-Q, which will be accessible on Aurinia's website at www.auriniapharma.com , on SEDAR at www.sedar.com or on EDGAR at www.sec.gov/edgar .

Conference Call Details

Aurinia will host a conference call and webcast to discuss the quarter ended March 31, 2022 financial results today, Tuesday, May 10, 2022 at 8:30 a.m. ET. The audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com . In order to participate in the conference call, please dial +1 (866) 682-6100 / (862) 298-0702 (Toll-free U.S. & Canada). An audio webcast can be accessed under "News/Events" through the "Investors" section of the Aurinia corporate website at www.auriniapharma.com . A replay of the webcast will be available on Aurinia's website.

About Lupus Nephritis

LN is a serious progression of systemic lupus erythematosus (SLE), a chronic and complex autoimmune disease. About 200,000-300,000 people live with SLE in the U.S. and approximately one out of three of these individuals have already developed LN at the time of SLE diagnosis. If poorly controlled, LN can lead to permanent and irreversible tissue damage within the kidney, resulting in kidney failure. Black and Asian individuals with SLE are four times more likely to develop LN and individuals with Hispanic ancestry are approximately twice as likely to develop the disease when compared with Caucasian individuals. Black and Hispanic individuals with SLE also tend to develop LN earlier and have poorer outcomes when compared to Caucasian individuals.

About Aurinia

Aurinia Pharmaceuticals is a fully integrated biopharmaceutical company focused on delivering therapies to treat targeted patient populations that are impacted by serious diseases with a high unmet medical need. In January 2021, the Company has introduced LUPKYNIS (voclosporin), the first FDA-approved oral therapy dedicated for the treatment of adult patients with active LN. The Company's head office is in Victoria, British Columbia, its U.S. commercial office is in Rockville, Maryland. The Company focuses its development efforts globally.

Forward-Looking Statements

Certain statements made in this press release may constitute forward-looking information within the meaning of applicable Canadian securities law and forward-looking statements within the meaning of applicable United States securities law. These forward-looking statements or information include but are not limited to statements or information with respect to: Aurinia's estimates as to annual net revenue from sales of LUPKYNIS in the range of $115-$135 million in 2022; Aurinia's estimates as to the number of patients with SLE in the U.S. and the proportion of those persons who have developed LN at time of SLE diagnosis; Aurinia being confident that it is poised for growth and success; Aurinia's belief that it has sufficient financial resources to fund its current plans for at least the next few years; and the expected timing for the EMA CHMP opinion and EC decision relating to the EMA MAA. It is possible that such results or conclusions may change. Words such as "anticipate", "will", "believe", "estimate", "expect", "intend", "target", "plan", "goals", "objectives", "may" and other similar words and expressions, identify forward-looking statements. We have made numerous assumptions about the forward-looking statements and information contained herein, including among other things, assumptions about: the accuracy of reported data from third party studies and reports; the number, and timing of receipt, of PSFs and their rate of conversion into patients on therapy; that Aurinia's intellectual property rights are valid and do not infringe the intellectual property rights of third parties; Aurinia's assumptions relating to the capital required to fund operations; the assumption that Aurinia's current good relationships with its suppliers, service providers and other third parties will be maintained; assumptions relating to the burn rate of Aurinia's cash for operations; the relationship between COVID vaccinations and patient treatment; assumptions related to timing of interactions with regulatory bodies; and that Aurinia's third party service providers will comply with their contractual obligations. Even though the management of Aurinia believes that the assumptions made, and the expectations represented by such statements or information are reasonable, there can be no assurance that the forward-looking information will prove to be accurate.

Forward-looking information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance, or achievements of Aurinia to be materially different from any future results, performance or achievements expressed or implied by such forward-looking information. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in forward-looking statements or information. Such risks, uncertainties and other factors include, among others, the following: Aurinia's actual future financial and operational results may differ from its expectations; difficulties Aurinia may experience in completing the commercialization of voclosporin; the market for the LN business may not be as estimated; Aurinia may have to pay unanticipated expenses; Aurinia may not be able to obtain sufficient supply to meet commercial demand for voclosporin in a timely fashion; unknown impact and difficulties imposed by the COVID-19 pandemic on Aurinia's business operations including nonclinical, clinical, regulatory and commercial activities; the results from Aurinia's clinical studies and from third party studies and reports may not be accurate; Aurinia's third party service providers may not, or may not be able to, comply with their obligations under their agreements with Aurinia; regulatory bodies may not grant approvals on conditions acceptable to Aurinia and its business partners, or at all; and Aurinia's assets or business activities may be subject to disputes that may result in litigation or other legal claims. Although Aurinia has attempted to identify factors that would cause actual actions, events, or results to differ materially from those described in forward-looking statements and information, there may be other factors that cause actual results, performances, achievements, or events to not be as anticipated, estimated or intended. Also, many of the factors are beyond Aurinia's control. There can be no assurance that forward-looking statements or information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, you should not place undue reliance on forward-looking statements or information. All forward-looking information contained in this press release is qualified by this cautionary statement. Additional information related to Aurinia, including a detailed list of the risks and uncertainties affecting Aurinia and its business, can be found in Aurinia's most recent Annual Report on Form 10-K available by accessing the Canadian Securities Administrators' System for Electronic Document Analysis and Retrieval (SEDAR) website at www.sedar.com or the U.S. Securities and Exchange Commission's Electronic Document Gathering and Retrieval System (EDGAR) website at www.sec.gov/edgar , and on Aurinia's website at www.auriniapharma.com .

AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

March 31, 2022

December 31, 2021

(unaudited)

ASSETS

Current assets

Cash, cash equivalents and restricted cash

$

132,542

$

231,900

Short-term investments

286,210

234,178

Accounts receivable, net

20,401

15,414

Inventories, net

26,266

19,326

Prepaid expenses and other current assets

12,199

12,506

Total current assets

477,618

513,324

Non-current assets

Other non-current assets

11,838

11,838

Property and equipment, net

4,332

4,418

Acquired intellectual property and other intangible assets, net

7,882

8,404

Right-of-use assets

5,232

5,383

Total assets

506,902

543,367

LIABILITIES

Current liabilities

Accounts payable and accrued liabilities

32,327

34,947

Other current liabilities

502

4,640

Operating lease liabilities

1,009

1,059

Total current liabilities

33,838

40,646

Non-current liabilities

Deferred compensation and other non-current liabilities

17,379

15,950

Operating lease liabilities

7,562

7,680

Total liabilities

58,779

64,276

SHAREHOLDER'S EQUITY

Common shares - no par value, unlimited shares authorized, 141,742 and 141,600 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively

1,178,807

1,177,051

Additional paid-in capital

64,686

59,014

Accumulated other comprehensive loss

(1,618)

(852)

Accumulated deficit

(793,752)

(756,122)

Total shareholders' equity

448,123

479,091

Total liabilities and shareholders' equity

$

506,902

$

543,367

AURINIA PHARMACEUTICALS INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share data)

Three months ended

March 31,

2022

2021

(unaudited)

Revenue

Product revenue, net

$

21,492

$

884

License and collaboration revenue

133

30

Total revenue, net

21,625

914

Operating expenses

Cost of sales

256

48

Selling, general and administrative

45,197

39,805

Research and development

12,620

9,833

Other expense, net

1,434

1,771

Total cost of sales and operating expenses

59,507

51,457

Loss from operations

(37,882)

(50,543)

Interest income

262

172

Net loss before income taxes

(37,620)

(50,371)

Income tax expense

10

8

Net loss

$

(37,630)

$

(50,379)

Basic and diluted loss per share

$

(0.27)

$

(0.40)

Weighted-average common shares outstanding used in computation of basic and diluted loss per share

141,675

127,401

Investor/Media Contact:
Dana Lynch
Corporate Communications, Aurinia
dlynch@auriniapharma.com

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AUP:CA,AUPH

CHMP Recommends European Commission Approval of Upadacitinib for the Treatment of Adults with Moderate to Severe Ulcerative Colitis

  • CHMP positive opinion is based on results from three Phase 3 studies: two for induction and one for maintenance 1-3
  • Ulcerative colitis is a chronic, immune-mediated inflammatory bowel disease that can lead to substantial burden and often disability among patients 4-6
  • If approved by the European Commission (EC), this would be upadacitinib's fifth therapeutic indication in the EU
  • The EC decision is anticipated in the third quarter of 2022

ABBVie (NYSE: ABBV) today announced the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of upadacitinib (RINVOQ ® 45 mg [induction dose] and 15 mg and 30 mg [maintenance dose]) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response, lost response or were intolerant to either conventional therapy or a biologic agent.*

UC is the chronic inflammation of the large intestine, usually beginning in the rectum and lower colon, but may also spread continuously to involve the entire colon, which could lead to a significant burden and disability for patients. 5 Living with UC impacts all aspects of a patient's life, largely due to unpredictable symptoms such as bowel urgency, abdominal pain, rectal bleeding and bowel incontinence. 5

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Class Action Reminder: Kessler Topaz Meltzer & Check, LLP Reminds Investors of Securities Fraud Class Action Lawsuit Filed Against AbbVie, Inc.

The law firm of Kessler Topaz Meltzer & Check, LLP(www.ktmc.com) informs investors that the firm has filed a securities class action lawsuit against ABBVie, Inc. (ABBVie) (NYSE:ABBV) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period

CLICK HERE TO SUBMIT YOUR ABBVIE LOSSES. YOU CAN ALSO CLICK ON THE FOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/abbvie-inc?utm_source=PR&utm_medium=link&utm_campaign=abbvie&mktm=r

CANNOT VIEW THIS VIDEO? PLEASE CLICK HERE

TO VIEW OUR COMPLAINT, PLEASE CLICK HERE

LEAD PLAINTIFF DEADLINE: JUNE 6, 2022

CLASS PERIOD: APRIL 30, 2021 through AUGUST 31, 2021

CONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS:

James Maro, Esq. (484) 270-1453 or Email at info@ktmc.com

Kessler Topaz is one of the world's foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our securities fraud litigators are regularly recognized as leaders in the field individually and our firm is both feared and respected among the defense bar and the insurance bar. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent.

ABBVIE'S ALLEGED MISCONDUCT

AbbVie is one of the world's largest pharmaceutical companies. The company's revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVie's future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humira's lost sales. Rinvoq-an anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes-was touted as one such drug. Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases.

As is relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of RA, it required an additional safety trial to evaluate Xeljanz's risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz's use could lead to serious heart-related issue, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the Class Period, Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks.

However, investors began to learn the truth about Rinvoq's significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021, to close at $112.98 per share on June 25, 2021.

Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021.

After the Class Period, on December 3, 2021, AbbVie announced that the FDA had updated Rinvoq's label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed. On January 11, 2022, Defendants admitted that these changes to Rinvoq's label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq's sales in 2025.

The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the company's business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis, As a result of the Defendants' wrongful acts and omissions, and the significant decline in the market value of AbbVie's securities, AbbVie investors have suffered significant damages.

WHAT CAN I DO?

AbbVieinvestors may, no later than June 6, 2022, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLPor other counsel, or may choose to do nothing and remain an absent class member. Kessler Topaz Meltzer & Check, LLP encourages AbbVie investors who have suffered significant losses to contact the firm directly to acquire more information.

CLICK HERE TO SIGN UP FOR THE CASE

WHO CAN BE A LEAD PLAINTIFF?

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.

CONTACT:

Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
280 King of Prussia Road
Radnor, PA 19087
(484) 270-1453
info@ktmc.com

SOURCE: Kessler Topaz Meltzer & Check, LLP



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https://www.accesswire.com/702145/Class-Action-Reminder-Kessler-Topaz-Meltzer-Check-LLP-Reminds-Investors-of-Securities-Fraud-Class-Action-Lawsuit-Filed-Against-AbbVie-Inc

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Kessler Topaz Meltzer & Check, LLP Reminds Investors of June 6, 2022 Deadline in Securities Fraud Class Action against AbbVie, Inc. and Urges Investors with Substantial Losses to Contact the Firm

The law firm of Kessler Topaz Meltzer & Check, LLP ( www.ktmc.com ) informs investors that the firm has filed a securities class action lawsuit in the United States District Court for the Northern District of Illinois against ABBVie, Inc. (ABBVie) ( NYSE: ABBV ) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period").

CLICK HERE TO SUBMIT YOUR ABBVIE LOSSES . YOU CAN ALSO CLICK ON THE FOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/abbvie-inc?utm_source=PR&utm_medium=link&utm_campaign=abbvie&mktm=r

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ROSEN, Top Ranked Investor Counsel, Encourages AbbVie Inc. Investors to Secure Counsel Before Important June 6 Deadline in Securities Class Action - ABBV

 WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of the securities of ABBVie Inc. (NYSE: ABBV) between April 30, 2021 and August 31, 2021, inclusive (the "Class Period"), of the important June 6, 2022 lead plaintiff deadline.

SO WHAT: If you purchased AbbVie securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrangement.

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CLASS ACTION ALERT: Kessler Topaz Meltzer & Check, LLP Reminds AbbVie, Inc. Investors of Upcoming Lead Plaintiff Deadline

The law firm of Kessler Topaz Meltzer & Check, LLP(www.ktmc.com) informs investors that the firm has filed a securities class action lawsuit against ABBVie, Inc. (ABBVie) (NYSE:ABBV) on behalf of all persons and entities who purchased or otherwise acquired ABBVie securities between April 30, 2021, and August 31, 2021, inclusive (the "Class Period

CLICK HERE TO SUBMIT YOUR ABBVIE LOSSES. YOU CAN ALSO CLICK ON THE FOLLOWING LINK OR COPY AND PASTE IN YOUR BROWSER: https://www.ktmc.com/new-cases/abbvie-inc?utm_source=PR&utm_medium=link&utm_campaign=abbvie&mktm=r

CANNOT VIEW THIS VIDEO? PLEASE CLICK HERE

TO VIEW OUR COMPLAINT, PLEASE CLICK HERE

LEAD PLAINTIFF DEADLINE: JUNE 6, 2022

CLASS PERIOD: APRIL 30, 2021 through AUGUST 31, 2021

CONTACT AN ATTORNEY TO DISCUSS YOUR RIGHTS:

James Maro, Esq. (484) 270-1453 or Email at info@ktmc.com

Kessler Topaz is one of the world's foremost advocates in protecting the public against corporate fraud and other wrongdoing. Our securities fraud litigators are regularly recognized as leaders in the field individually and our firm is both feared and respected among the defense bar and the insurance bar. We are proud to have recovered billions of dollars for our clients and the classes of shareholders we represent.

ABBVIE'S ALLEGED MISCONDUCT

AbbVie is one of the world's largest pharmaceutical companies. The company's revenues will come under significant pressure in the coming years when its best-selling drug, Humira, will lose patent protection in 2023. Accordingly, AbbVie's future revenue and earnings depend in large part on its ability to develop new sources of revenue to offset Humira's lost sales. Rinvoq-an anti-inflammatory drug manufactured by AbbVie and used to treat rheumatoid arthritis (RA) and other diseases by inhibiting Janus kinase (JAK) enzymes-was touted as one such drug. Rinvoq was initially approved in the United States to treat only moderate to severe RA. However, AbbVie was actively pursuing additional treatment indications and, in 2020, asked the U.S. Food and Drug Administration (FDA) to approve Rinvoq for the treatment of several other diseases.

As is relevant here, Rinvoq is similar to other JAK inhibitor drugs, including Xeljanz, manufactured by Pfizer Inc. When the FDA approved Xeljanz in 2012 for the treatment of RA, it required an additional safety trial to evaluate Xeljanz's risk of triggering certain serious side effects. Beginning in February 2019, the FDA repeatedly warned the public that the safety trial indicated that Xeljanz's use could lead to serious heart-related issue, cancer, and other adverse events. Notwithstanding the similarities between Rinvoq and Xeljanz, during the Class Period, Defendants assured investors that Rinvoq was far safer than Xeljanz and not subject to the same regulatory risks.

However, investors began to learn the truth about Rinvoq's significant risks on June 25, 2021, when AbbVie revealed that the FDA was delaying its review of expanded treatment applications for Rinvoq due to the safety concerns associated with Xeljanz. On this news, the price of AbbVie common stock declined $1.76 per share, or approximately 1.5%, from a close of $114.74 per share on June 24, 2021, to close at $112.98 per share on June 25, 2021.

Then, on September 1, 2021, the FDA announced that final results from the Xeljanz safety trial established an increased risk of serious adverse events, even with low doses of Xeljanz. As a result, the FDA determined that it would require new and updated warnings for Xeljanz and Rinvoq because Rinvoq "share[s] similar mechanisms of action with Xeljanz" and "may have similar risks as seen in the Xeljanz safety trial." The FDA also indicated that it would further limit approved indications for Rinvoq as a result of these safety concerns. On this news, the price of AbbVie common stock declined $8.51 per share, or more than 7%, from a close of $120.78 per share on August 31, 2021, to close at $112.27 per share on September 1, 2021.

After the Class Period, on December 3, 2021, AbbVie announced that the FDA had updated Rinvoq's label to require additional safety warnings and limit marketing of Rinvoq to only its use after treatment with other drugs has failed. On January 11, 2022, Defendants admitted that these changes to Rinvoq's label would negatively impact sales, forcing the Company to reduce its long-term guidance for Rinvoq's sales in 2025.

The complaint alleges that, throughout the Class Period, the Defendants made materially false and/or misleading statements, about the company's business and operations. Specifically, Defendants misrepresented and/or failed to disclose that: (1) safety concerns about Xeljanz extended to Rinvoq and other JAK inhibitors; (2) as a result, it was likely that the FDA would require additional safety warnings for Rinvoq and would delay the approval of additional treatment indications for Rinvoq; and (3) therefore, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis, As a result of the Defendants' wrongful acts and omissions, and the significant decline in the market value of AbbVie's securities, AbbVie investors have suffered significant damages.

WHAT CAN I DO?

AbbVieinvestors may, no later than June 6, 2022, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLPor other counsel, or may choose to do nothing and remain an absent class member. Kessler Topaz Meltzer & Check, LLP encourages AbbVie investors who have suffered significant losses to contact the firm directly to acquire more information.

CLICK HERE TO SIGN UP FOR THE CASE

WHO CAN BE A LEAD PLAINTIFF?

A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. The lead plaintiff is usually the investor or small group of investors who have the largest financial interest and who are also adequate and typical of the proposed class of investors. The lead plaintiff selects counsel to represent the lead plaintiff and the class and these attorneys, if approved by the court, are lead or class counsel. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.

ABOUT KESSLER TOPAZ MELTZER & CHECK, LLP

Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country and around the world. The firm has developed a global reputation for excellence and has recovered billions of dollars for victims of fraud and other corporate misconduct. All of our work is driven by a common goal: to protect investors, consumers, employees and others from fraud, abuse, misconduct and negligence by businesses and fiduciaries. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.

CONTACT:

Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
280 King of Prussia Road
Radnor, PA 19087
(484) 270-1453
info@ktmc.com

SOURCE: Kessler Topaz Meltzer & Check, LLP



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https://www.accesswire.com/702143/CLASS-ACTION-ALERT-Kessler-Topaz-Meltzer-Check-LLP-Reminds-AbbVie-Inc-Investors-of-Upcoming-Lead-Plaintiff-Deadline

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SHAREHOLDER ALERT: ABBV NTRA MULN: The Law Offices of Vincent Wong Reminds Investors of Important Class Action Deadlines

The Law Offices of Vincent Wong announce that class actions have commenced on behalf of certain shareholders in the following companies. If you suffered a loss you have until the lead plaintiff deadline to request that the court appoint you as lead plaintiff. There will be no obligation or cost to you

AbbVie Inc. (NYSE:ABBV)

If you suffered a loss, contact us at:https://www.wongesq.com/pslra-1/abbvie-inc-loss-submission-form-2?prid=27532&wire=1
Lead Plaintiff Deadline: June 6, 2022
Class Period: April 30, 2021 - August 31, 2021

News Provided by ACCESSWIRE IA via QuoteMedia

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