On October 30, 2020 Kyowa Hakko Kirin reported that (Press release, Kyowa Hakko Kirin, OCT 30, 2020, View Source [SID1234569509])

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1. Consolidated Financial Results for the Nine Months Ended September 30, 2020

(2) Consolidated financial position

2. Dividends

3. Consolidated Earnings Forecasts for the Fiscal Year Ending December 31, 2020 (from January 1, 2020 to December 31, 2020)

(1) Changes to significant subsidiaries during the period (Changes of specified subsidiaries resulting in changes in the scope of consolidation during the period under review):

No (2) Changes in accounting policies, and accounting estimates: a. Changes in accounting policies required by IFRS: No b. Changes in accounting policies other than a. above: No c. Changes in accounting estimates:

No (3) Number of shares issued (ordinary shares) Quarterly financial results reports are exempt from quarterly review conducted by certified public accountants or an audit corporation.

* Notice regarding the appropriate use of the earnings forecasts and other special comments The forward-looking statements, including earnings forecasts, contained in these materials are based on the information currently available to the Company and on certain assumptions deemed to be reasonable by management. As such, they do not constitute guarantees by the Company of future performance. Actual results may differ materially from these projections for a wide variety of reasons.

1. Operating Results and Financial Statements

(1) Summary of Consolidated Business Performance

1) Overview of results Since applying IFRS, the Group adopts "core operating profit" as a level of profit that shows the recurring profitability from operating activities. Core operating profit is calculated by deducting "selling, general and administrative expenses" and "research and development expenses" from "gross profit," and adding "share of profit (loss) of investments accounted for using equity method" to the amountFor the nine months ended September 30, 2020 (January 1, 2020 to September 30, 2020), revenue was ¥234.0 billion (up 3.8% compared to the same period of the previous fiscal year), and core operating profit was ¥50.7 billion (up 10.8%). Profit attributable to owners of parent was ¥37.5 billion (down 33.4%).

The increase in revenue was the result of steady growth of global strategic products in North America and EMEA and strong sales in Asia, mainly in China, despite the impact of lower revenue in Japan from the reduction in drug price standards and the switching to Darbepoetin Alfa Injection Syringe [KKF], an authorized generic of NESP, a renal anemia treatment drug, among others. The increase in core operating profit was the result of an increase in gross profit due to an increase in overseas revenue, despite an increase in selling, general and administrative expenses.

 Profit attributable to owners of parent decreased as a result of the absence of the profit from discontinued operations recorded in the same period of the previous fiscal year, despite lower business restructuring expenses and impairment losses in addition to an increase in core operating profit. 2) Revenue by regional control function

 Revenue in Japan decreased year on year because of the significant impact of switching to Darbepoetin Alfa Injection Syringe [KKF], an authorized generic of NESP, a renal anemia treatment drug whose patent has expired, in addition to the impact of the reductions in drug price standards implemented in October 2019 and April 2020, despite the growth in sales of new product groups.

 Darbepoetin Alfa Injection Syringe [KKF] achieved rapid progress in switching from NESP, a renal anemia treatment drug.

Duvroq, an oral treatment for renal anemia, was launched in August, and it has started penetrating the market favorably.

 Revenue from Patanol, anti-allergy eye drops, and ALLELOCK, an anti-allergy agent, decreased as a result of smaller pollen counts and the impact of the suppression of examinations, etc. due to the novel coronavirus disease (COVID-19).  Revenue from ORKEDIA, a treatment for secondary hyperparathyroidism, increased. Meanwhile, revenue from REGPARA, a treatment for secondary hyperparathyroidism, decreased due to factors such as switching to ORKEDIA and the impact of rival products.

 Revenue from ROMIPLATE, a treatment for chronic idiopathic thrombocytopenic purpura, increased as a result of receiving approval of its indication for treatment of patients with aplastic anemia who have had an inadequate response to conventional therapy, in June 2019.

 Firm growth in revenue was realized for G-Lasta, an agent for decreasing the incidence of febrile neutropenia, and Rituximab BS [KHK], an anticancer agent.

 In December 2019, Crysvita, a treatment for FGF23-related diseases, and HARUROPI, a Parkinson’s disease treatment patch, were launched and they have been penetrating the market favorably.

 Revenue in North America increased year on year due to the steady growth of global strategic products.

 Revenue from Crysvita, a treatment for X-linked hypophosphatemia, have been growing steadily since its launch in 2018.

 Revenue from POTELIGEO, an anticancer agent, stayed at the same level as in the same period of the previous fiscal year due to the impact of the COVID-19 pandemic.

 NOURIANZ (product name in Japan: NOURIAST), an antiparkinsonian agent which was launched in October 2019, has been penetrating the market favorably.

 Revenue in EMEA increased year on year due to the steady growth of global strategic products.

 Revenue from Crysvita, a treatment for X-linked hypophosphatemia, have been growing steadily as the number of countries where it has been released has been increasing since its launch in 2018.

 In Germany, POTELIGEO, an anticancer agent, was launched in June, and has started penetrating the market favorably.

 Revenue in Asia/Oceania increased year on year, reflecting strong sales particularly in China.

 Revenue from REGPARA, a treatment for secondary hyperparathyroidism, increased compared to the same period of the previous fiscal year due to market expansion in China.

 Revenue from Others decreased year on year.

 Revenue decreased from the same period of the previous fiscal year due mainly to a decline in milestone revenue despite an increase in royalties revenue from AstraZeneca in relation to benralizumab. Core operating profit increased compared to the same period of the previous fiscal year due to an increase in overseas revenue mainly from global strategic products, despite a decrease in revenue in Japan and an increase in selling, general and administrative expenses associated with sales of global strategic products.

(2) Summary of Consolidated Financial PositionAssets as of September 30, 2020, were ¥781.2 billion, a decrease of ¥3.3 billion compared to the end of the previous fiscal year.

 Non-current assets increased by ¥17.7 billion to ¥353.5 billion, due mainly to increases in intangible assets associated with in-licensing of development products and deferred tax assets.

 Current assets decreased by ¥21.0 billion to ¥427.7 billion, due mainly to a decrease in cash reserves (total of cash and cash equivalents and loans receivable from parent) due to the purchase of intangible assets, income taxes and dividends paid, despite large increases in cash and cash equivalents due to the impact of an increase of ¥248.0 billion within loans receivable from parent with loan periods of three months or less included in the scope of cash and cash equivalents.

 Liabilities as of September 30, 2020, were ¥96.0 billion, a decrease of ¥10.2 billion compared to the end of the previous fiscal year, due mainly to decreases in income taxes payable and trade and other payables. 45.8 50.7 +7.0 +0.8 +1.4-4.3 0.0 20.0 40.0 60.0 Jan.-Sep. 2019 Gross profit Selling, general and administrative expenses Research and development expenses Share of profit (loss) of investments accounted for using equity method Jan.-Sep. 2020 +4.9 8 Kyowa Kirin Co., Ltd. (4151)

 Equity as of September 30, 2020, was ¥685.2 billion, an increase of ¥6.9 billion compared to the end of the previous fiscal year, due mainly to an increase due to the recording of profit attributable to owners of parent, despite a decrease due to the payment of dividends as well as a decrease in exchange differences on translation of foreign operations resulting from the impact of exchange rates, etc. As a result, the ratio of equity attributable to owners of parent to total assets as of the end of the third quarter was 87.7%, an increase of 1.3 percentage points compared to the end of the previous fiscal year.

(3) Summary of Consolidated Cash Flows Cash and cash equivalents as of September 30, 2020, were ¥285.0 billion, an increase of ¥264.2 billion compared with the balance of ¥20.8 billion as of December 31, 2019, mainly as a result of the impact of an increase of ¥248.0 billion within loans receivable from parent with loan periods of three months or less included in the scope of cash and cash equivalents. The main contributing factors affecting cash flow during the nine months ended September 30, 2020 were as follows:

 Net cash provided by operating activities was ¥31.9 billion, a 17.5% decrease compared to the same period of the previous fiscal year. Major inflows included profit before tax of ¥44.2 billion and depreciation and amortization of ¥13.8 billion. Major outflows included income taxes paid of ¥26.6 billion.

 Net cash provided by investing activities was ¥258.7 billion, a 6,162.4% increase compared to the same period of the previous fiscal year. Major inflows included a net decrease of ¥285.7 billion in loans receivable from parent. Major outflows included ¥19.7 billion for purchase of intangible assets, and ¥7.8 billion for purchase of property, plant and equipment.

 Net cash used in financing activities was ¥25.9 billion, a 44.4% decrease compared to the same period of the previous fiscal year. Major outflows included dividends paid of ¥23.6 billion.

(4) Research and Development Activities Using cutting-edge biotechnology centered on antibody technology, we have made nephrology, oncology, immunology/allergy and central nervous system (CNS) the focus of research and development (R&D), and by investing resources efficiently, we aim to further speed up the creation of new medical value and drug creation. For the nine months ended September 30, 2020, the Group’s research and development expenses totaled ¥37.0 billion, and the progress of our main late-stage development products is as follows. ("◆" indicates the progress made during the third quarter of fiscal 2020.) Nephrology KRN321 (product name in Japan: NESP)

 In June, we obtained approval of its indication for treatment of renal anemia in patients receiving hemodialysis in China.Oncology KRN125 (product name in Japan: G-Lasta)

 In February, we started a phase I clinical study in Japan related to the development of an automated injection device for decreasing the incidence of febrile neutropenia in patients receiving cancer chemotherapy. ME-401 (generic name: Zandelisib)

 In the U.S., Europe, South Korea, Australia, etc., we are currently conducting a phase II clinical trial for treatment of follicular lymphoma. (In April, we concluded an agreement with MEI Pharma on global license, development, and commercialization.) KW-0761 (product name in Japan, U.S. and Europe: POTELIGEO)

 In the U.S., Europe, etc., we conducted a phase II clinical trial for treatment of adult T-cell leukemia/lymphoma, but we have discontinued all subsequent development from the perspective of portfolio management. Immunology and allergy KHK4827 (product name in Japan: LUMICEF)

 In June, we obtained approval of its indication for treatment of plaque psoriasis in China. Central nervous system (CNS) KW-6002 (product name in Japan: NOURIAST; product name in U.S.: NOURIANZ)

 In January, an application for approval of its indication for combination therapy with levodopa-based regimens for adult patients with Parkinson’s disease experiencing "off" episodes was accepted in Europe (application filed in November 2019). Other KRN23 (product name in Japan, U.S. and Europe: Crysvita)

 In February in the U.S., we obtained approval for partial changes to our biologics license application for approval of its indication for treatment of tumor induced osteomalacia that cannot be curatively resected or localized, and in June, we obtained approval of its indication for treatment of tumor induced osteomalacia that cannot be curatively resected or localized for adult patients and pediatric patients who are two years of age or older.

 In September, we obtained approval of its indication for treatment of X-linked hypophosphatemia in adolescent and adult patients in Europe.

 In September, we obtained approval of its indication for treatment of FGF23-related hypophosphatemic rickets and osteomalacia in South Korea.

(5) Summary of Consolidated Earnings Forecasts and Other Forward-looking Statements No revisions have been made to the consolidated earnings forecasts announced on July 30, 2020.

2. Condensed Quarterly Consolidated Financial Statements and Significant

Notes Thereto

(1) Condensed Quarterly Consolidated Statement of Financial Position

(1) Condensed Quarterly Consolidated Statement of Financial Position (continued)

(2) Condensed Quarterly Consolidated Statement of Profit or Loss and Condensed Quarterly Consolidated Statement of Comprehensive Income

(3) Condensed Quarterly Consolidated Statement of Changes in Equity

(3) Condensed Quarterly Consolidated Statement of Changes in Equity (continued)

(4) Condensed Quarterly Consolidated Statement of Cash Flows

(5) Notes to Condensed Quarterly Consolidated Financial Statements Notes on going concern assumption No applicable items. Segment information As the Bio-Chemicals business was categorized as a discontinued operation effective from the previous fiscal year, the Group omitted information by reportable segment as the Group consists of only the one reportable segment, which is the Pharmaceuticals business.

On October 30, 2020 Veracyte, Inc., (Nasdaq: VCYT) reported that findings from the first study evaluating the molecular drivers underlying multiple prognostic genomic breast cancer tests were published in the Journal of Clinical Oncology (JCO) (Press release, Veracyte, OCT 30, 2020, View Source [SID1234569479]). Results suggest that the genomic underpinnings of Veracyte’s Prosigna Breast Cancer Gene Signature Assay, particularly the test’s relative weighting of genes predicting tumor proliferation, may explain the classifier’s previously demonstrated, higher likelihood of predicting long-term risk of recurrence among certain breast cancer patients, compared to other breast cancer tests.

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The study compared the commercial forms of four breast cancer recurrence-risk tests: the PAM50-based Prosigna Risk of Recurrence (ROR), the Oncotype DX Risk Score (RS), EndoPredict (EP) and Breast Cancer Index (BCI). It expands upon a previous evaluation of these same tests using an identical dataset, which compared their ability to accurately predict 10-year distant disease recurrence.1 The new study was intended to help determine why these tests commonly generate discordant results and thereby help to inform long-term therapeutic decision-making.

Researchers evaluated 785 patient samples from the TransATAC dataset using each of the four tests and then compared the resulting recurrence risk scores. Their comparisons included the molecular features driving each of the scores, without the clinicopathologic features that are integrated into the final prognostic result for the Prosigna ROR, EP and BCI. All TransATAC samples were derived from the randomized ATAC (Anastrozole, Tamoxifen Alone or in Combination) clinical trial, which involves postmenopausal women with hormone receptor-positive, HER2-negative, early-stage breast cancer who had received five years of endocrine therapy. A genomic test result indicating low risk of distant disease recurrence (i.e., disease recurrence within 10 years) among this population suggests the potential for a patient to safely forego chemotherapy.

"Gene expression assays can help physicians identify which ER+ breast cancer patients can safely avoid chemotherapy, a decision that can have meaningful clinical and quality-of-life implications," said Matthew Ellis, MBBChir, Ph.D., FRCP, Baylor College of Medicine, and one of the developers of the PAM50 genomic signature. "However, the four most prominent genomic classifiers often provide discordant results. This study is the first to provide a molecular explanation of discordance, which will enhance insights into the respective value of each test, and therefore the most appropriate usage, particularly in determining risk of distant recurrence."

Study results showed that there was low correlation between the Oncotype DX RS and the Prosigna ROR score, and between the RS and BCI scores. Researchers subsequently determined that genes predicting tumor proliferation (i.e., the rate at which cancer cells divide) accounted for 72.5% of the difference between the RS and Prosigna score and 54.3% of the difference between the RS and BCI scores. Among the four tests, researchers found that the Prosigna ROR score relies most heavily on proliferation-related features, while the RS is determined much more strongly by estrogen-related features. Tumor proliferation is known to be an important and reliable indicator of distant disease recurrence and is indicative of response to chemotherapy.

"Clarity about the relative influence of the proliferation vs. estrogen modules in each of these gene expression assays is important for several reasons, including the fact that this information helps clinicians evaluate the relative benefit of endocrine therapy alone vs. endocrine therapy plus chemotherapy for individual patients," said Dr. Ellis.

The Prosigna Breast Cancer Prognostic Gene Signature Assay, which is powered by the PAM50 gene signature, uses advanced genomic technology to classify breast cancers based on key biomarkers and the likelihood of cancer recurrence. Outside of the United States, it is also utilized to provide breast cancer intrinsic subtype information. Veracyte acquired the Prosigna test from NanoString Technologies, Inc. in December 2019 as part of its acquisition of the exclusive global diagnostic rights to the nCounter Analysis System.

"The findings from this study further validate the molecular biology underlying the accuracy of our Prosigna test," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "We are grateful to the study’s investigators, who have provided the breast cancer community with important new data that will undoubtedly help inform treatment decisions for thousands of women."

About Prosigna

Prosigna is a prognostic Breast Cancer Gene Signature assay indicated in female breast cancer patients who have undergone either mastectomy or breast-conserving therapy in conjunction with locoregional treatment consistent with standard of care, either as a prognostic indicator for distant recurrence-free survival at 10 years in post-menopausal women with Hormone Receptor-Positive (HR+), lymph node-negative, Stage I or II breast cancer or lymph node-positive (1–3 positive nodes, or 4 or more positive nodes), Stage II or IIIA breast cancer to be treated with adjuvant endocrine therapy alone, when used in conjunction with other clinicopathological factors. Outside of the U.S., the Prosigna test also provides the intrinsic subtypes of the tumor tissue within three groups, low, intermediate and high by the nCounter technology with high accuracy by decentral performance.

The Prosigna test is FDA 510(k) cleared in the United States for use on the nCounter instrument and is available for use when ordered by a physician. The Prosigna test has received CE Mark, showing that it conforms with European Union regulations, and is available for use by healthcare professionals in the European Union and other countries that recognize the CE Mark, as well as in Canada, Israel, Australia, New Zealand and Hong Kong. The test is covered by Medicare and leading private payers in the United States and is widely covered by government and private payers in the countries where it is available.

On October 30, 2020 AbbVie (NYSE: ABBV) reported financial results for the third quarter ended September 30, 2020 (Press release, AbbVie, OCT 30, 2020, View Source [SID1234569478]).

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"We continue to be very well positioned for the long-term. Results from key growth products – including Skyrizi, Rinvoq and Ubrelvy – continue to track ahead of our expectations, our aesthetics portfolio is demonstrating a strong V-shaped recovery, our hematologic-oncology franchise is delivering double-digit growth and we’re advancing numerous attractive late-stage pipeline programs," said Richard A. Gonzalez, chairman and chief executive officer, AbbVie. "We are also executing effectively on Allergan integration initiatives with synergy and accretion targets tracking well."

Third-Quarter Results

Worldwide GAAP net revenues were $12.902 billion, an increase of 52.1 percent on a reported basis. Worldwide adjusted net revenues of $12.882 billion increased 4.1 percent on a comparable operational basis.
Global net revenues from the immunology portfolio were $5.790 billion, an increase of 14.8 percent on a reported basis, or 15.0 percent on an operational basis.
Global Humira net revenues of $5.140 billion increased 4.1 percent on a reported basis, or 4.4 percent on an operational basis. U.S. Humira net revenues were $4.189 billion, an increase of 7.7 percent. Internationally, Humira net revenues were $951 million, a decrease of 9.3 percent on a reported basis, or 8.0 percent on an operational basis, due to biosimilar competition.
Global Skyrizi net revenues were $435 million.
Global Rinvoq net revenues were $215 million.
Global net revenues from the hematologic oncology portfolio were $1.722 billion, an increase of 16.5 percent on a reported basis, or 16.4 percent on an operational basis.
Global Imbruvica net revenues were $1.370 billion, an increase of 9.0 percent, with U.S. net revenues of $1.119 billion and international profit sharing of $251 million.
Global Venclexta net revenues were $352 million, an increase of 59.0 percent on a reported basis, or 58.3 percent on an operational basis.
Global net revenues from the aesthetics portfolio were $967 million, a decrease of 3.1 percent on a comparable operational basis.
Global Botox Cosmetic net revenues were $393 million, a decrease of 2.2 percent on a comparable operational basis.
Global net revenues from the neuroscience portfolio were $1.249 billion, an increase of over 100.0 percent on a reported basis, or 12.1 percent on a comparable operational basis.
Global Botox Therapeutic net revenues were $523 million, a decrease of 1.8 percent on a comparable operational basis.
Global Vraylar net revenues were $358 million, an increase of 48.4 percent on a comparable operational basis.
Global Ubrelvy net revenues were $38 million.
On a GAAP basis, the gross margin ratio in the third quarter was 60.9 percent. The adjusted gross margin ratio was 81.7 percent.
On a GAAP basis, selling, general and administrative expense was 22.1 percent of net revenues. The adjusted SG&A expense was 21.1 percent of net revenues.
On a GAAP basis, research and development expense was 13.2 percent of net revenues. The adjusted R&D expense was 11.7 percent of net revenues, reflecting funding actions supporting all stages of our pipeline.
On a GAAP basis, the operating margin in the third quarter was 25.2 percent. The adjusted operating margin was 48.8 percent.
On a GAAP basis, net interest expense was $620 million.
On a GAAP basis, the tax rate in the quarter was 7.5 percent. The adjusted tax rate was 11.7 percent.
Diluted EPS in the third quarter was $1.29 on a GAAP basis. Adjusted diluted EPS, excluding specified items, was $2.83.
Note: "Comparable Operational" comparisons include full-quarter current year and prior year results for Allergan, which was acquired on May 8, 2020, as if the acquisition closed on January 1, 2019, and are presented at constant currency rates and reflect comparative local currency net revenues at the prior year’s foreign exchange rates. Refer to the Key Product Revenues schedules for further details. "Operational" comparisons are presented at constant currency rates and reflect comparative local currency net revenues at the prior year’s foreign exchange rates.

Recent Events

AbbVie announced that it has submitted an application for a new indication to the U.S. Food and Drug Administration (FDA) for Rinvoq (upadacitinib), a selective and reversible JAK inhibitor, for the treatment of adult patients with active ankylosing spondylitis (AS). AbbVie also submitted an application to the European Medicines Agency (EMA) for Rinvoq for the treatment of adult patients with active AS who have responded inadequately to conventional therapy. The applications are supported by data from SELECT-AXIS 1, a Phase 2/3 study in which Rinvoq demonstrated significant improvements in signs and symptoms in patients with active AS. In the study, twice as many patients receiving Rinvoq (52 percent) met the primary endpoint of Assessment of SpondyloArthritis International Society (ASAS) 40 response versus placebo (26 percent) at week 14. The safety profile of Rinvoq in AS was consistent with previously reported studies across therapeutic areas, including rheumatoid arthritis (RA), atopic dermatitis (AD) and psoriatic arthritis (PsA), with no new significant safety risks detected.
AbbVie announced that it submitted applications to the FDA and EMA seeking approval for Rinvoq for the treatment of adults (15 mg and 30 mg, once daily) and adolescents (15 mg, once daily) with moderate to severe AD. The applications are supported by data from three pivotal Phase 3 studies. In all three studies, Rinvoq met the co-primary and all secondary endpoints, demonstrating significant improvement in skin clearance and reduction in itch in adults and adolescents with moderate to severe AD compared to placebo. No new safety risks of Rinvoq were observed in these studies compared to the safety profile observed in patients with RA, PsA or AS receiving Rinvoq.
AbbVie announced the FDA full approval of Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. The FDA had previously granted accelerated approval to Venclexta for this indication in 2018. The approval is supported by data from a series of trials including two Phase 3 trials – VIALE-A and VIALE-C. The VIALE-A trial showed that significantly more patients treated with Venclexta in combination with azacitidine achieved complete remission and lived longer versus patients treated with azacitidine alone. Additionally, The National Comprehensive Cancer Network (NCCN) guidelines recommend the Venclexta and azacitidine combination as a Category 1 Preferred AML treatment regimen for patients ineligible for intensive chemotherapy. Venetoclax is being developed by AbbVie and Roche and is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
AbbVie and I-Mab signed a broad, global collaboration agreement for the development and commercialization of lemzoparlimab, an innovative anti-CD47 monoclonal antibody internally discovered and developed by I-Mab for the treatment of multiple cancers. The collaboration provides AbbVie with an exclusive global license, excluding greater China, to develop and commercialize lemzoparlimab and both companies will have the potential to expand the collaboration to additional transformative therapies. Under the terms of the agreement, AbbVie will pay I-Mab $180 million in an upfront payment to exclusively license lemzoparlimab, along with $20 million in a milestone payment based on Phase 1 lemzoparlimab trial results. I-Mab will be eligible to receive up to an additional $1.74 billion in success-based milestone payments.
At the 2020 Virtual Migraine Trust International Symposium (MTIS) AbbVie presented 15 abstracts evaluating the safety, efficacy, and impact on patients and the healthcare system of AbbVie’s migraine treatment and prevention portfolio. Presentations included new data from the Phase 3 ADVANCE trial evaluating investigational medicine atogepant for the preventive treatment of migraine; real-world evidence assessing safety, tolerability, and potential benefits of treatment with Botox (onabotulinumtoxinA) in combination with calcitonin gene–related peptide (CGRP) monoclonal antibodies (mAbs) for chronic migraine prevention; and Phase 3 data measuring the efficacy and safety of Ubrelvy (ubrogepant) for the acute treatment of migraine with mild pain.
At the 2020 International Congress of Parkinson’s Disease and Movement Disorders AbbVie presented 18 abstracts that highlighted new and updated data evaluating AbbVie’s neuroscience portfolio and pipeline. Presentations included final data from the Phase 3 12-week DYSCOVER study, the first randomized trial of Duodopa (levodopa/carbidopa intestinal gel) (LCIG) on the duration and severity of dyskinesia in patients with advanced Parkinson’s disease (PD). Overall, the results of this pivotal study demonstrated clinically meaningful benefit with LCIG treatment in reducing dyskinesia compared to optimized medical treatment in patients with advanced PD.
AbbVie announced that the FDA granted Orphan Drug and Fast Track designations for elezanumab (ABT-555), an investigational treatment for patients following spinal cord injury. Elezanumab is currently in phase 2 studies for the treatment of spinal cord injuries, multiple sclerosis and acute ischemic stroke.
Allergan Aesthetics presented 4 abstracts at the annual American Society for Dermatologic Surgery (ASDS) virtual meeting. Presentations included data on patient satisfaction following chin augmentation with hyaluronic acid fillers as well as patient satisfaction and the efficacy of treatment of upper facial lines with Botox.
Allergan Aesthetics entered into an agreement with Luminera, a privately held aesthetics company based in Israel, to acquire Luminera’s full dermal filler portfolio and R&D pipeline further enhancing Allergan Aesthetics’ leading dermal filler portfolio. Luminera’s key value driver for the future is HArmonyCa, an innovative dermal filler intended for facial soft tissue augmentation comprised of a combination of cross-linked hyaluronic acid (HA) with embedded calcium hydroxyapatite (CaHA) microspheres that is highly differentiated in the dermal filler category. HArmonyCa is currently commercially available in Israel and Brazil and Allergan Aesthetics will continue to develop this product for its International and U.S. markets.
Allergan Aesthetics and Skinbetter Science announced the launch of a new long-term, educational initiative – DREAM: Driving Racial Equity in Aesthetic Medicine. The DREAM Initiative is committed to furthering the principles of racial and ethnic diversity, inclusion, respect and understanding in the fields of dermatology and plastic surgery.
AbbVie announced positive top-line results from the Phase 3 GEMINI 1 and GEMINI 2 trials evaluating AGN-190584, an ophthalmic solution of pilocarpine 1.25%, for the treatment of symptoms associated with presbyopia. In both studies, AGN-190584 met the primary endpoint, demonstrating a statistically significant improvement in near vision. The majority of secondary endpoints were also met in both Phase 3 studies. Additional details from the GEMINI 1 and GEMINI 2 studies will be presented at future medical meetings and will serve as the basis for a New Drug Application (NDA) submission to the FDA in the first half of 2021.
AbbVie and Harvard University announced a collaborative research alliance, launching a multi-pronged effort at Harvard Medical School to study and develop novel therapies against emergent viral infections, with a focus on those caused by coronaviruses and by viruses that lead to hemorrhagic fever. AbbVie will provide $30 million over three years and additional in-kind support leveraging AbbVie’s scientists, expertise and facilities to advance collaborative research and early-stage development efforts across five program areas that address a variety of therapeutic modalities including immunity and immunopathology, host targeting for antiviral therapies, antibody therapeutics, small molecules and translational development.
Full-Year 2020 Outlook

AbbVie is updating its GAAP diluted EPS guidance for the full-year 2020 from $4.12 to $4.22 to $3.89 to $3.91, which includes the results of Allergan from May 8, 2020 through December 31, 2020.

AbbVie is updating its adjusted diluted EPS for the full-year 2020 from $10.35 to $10.45 to $10.47 to $10.49, which includes the results of Allergan from May 8, 2020 through December 31, 2020, representing annualized net accretion from the Allergan transaction of 12 percent. The combined company’s 2020 adjusted diluted EPS guidance excludes $6.58 per share of intangible asset amortization expense, non-cash charges for contingent consideration adjustments and other specified items.

Company Declares Dividend Increase of 10.2 Percent

AbbVie is announcing today that its board of directors declared an increase in the company’s quarterly cash dividend from $1.18 per share to $1.30 per share beginning with the dividend payable on February 16, 2021 to shareholders of record as of January 15, 2021. This reflects an increase of approximately 10.2 percent, continuing AbbVie’s strong commitment to returning cash to shareholders through a growing dividend. Since the company’s inception in 2013, AbbVie has increased its quarterly dividend by 225 percent. AbbVie is a member of the S&P Dividend Aristocrats Index, which tracks companies that have annually increased their dividend for at least 25 consecutive years.

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, women’s health and gastroenterology, in addition to products and services across its 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 third-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 2020 and 2019 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. The company’s 2020 financial guidance is also being provided on both a reported and a non-GAAP basis.

On October 30, 2020 Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) reported financial results for the three- and nine-months ending September 30, 2020 and provided an operating forecast and program updates (Press release, Ligand, OCT 30, 2020, View Source [SID1234569477]). Ligand management will host a conference call with slides today beginning at 8:30 a.m. Eastern time to discuss this announcement and answer questions.

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"Our business is performing very well across the board. We are pleased to be reporting strong third quarter financial results and foresee substantial momentum and accelerating growth as we close out 2020 and move into 2021," said John Higgins, Chief Executive Officer of Ligand. "Revenue is tracking well against the guidance we raised throughout the year, and we are pleased with our earnings performance with adjusted diluted EPS coming in much higher than our outlook at the start of 2020."

Higgins continued, "Beyond robust financial performance, we closed three acquisitions in the past three months, with Pfenex in particular providing significant P&L contribution and a major new technology platform backed by top-tier partnering contracts. We are proud of our contribution to helping make Gilead’s Veklury possible as the first and only FDA approved treatment for COVID-19. Our core business is very strong and forms the foundation of Ligand’s value, but we certainly see the surge in Captisol business due to Veklury as meaningful upside now and over the next few quarters. Captisol material sales will provide Ligand increased cash flow and, in turn, the opportunity to invest in other areas to drive future growth."

Third Quarter 2020 Financial Results

Total revenues for the third quarter of 2020 were $41.8 million, compared with $24.8 million for the same period in 2019. Royalties for the third quarter of 2020 were $9.0 million, compared with $9.8 million for the same period in 2019. Royalties for the third quarter of 2020 and 2019 primarily consisted of royalties from Kyprolis and EVOMELA. Captisol sales were $23.4 million for the third quarter of 2020, compared with $6.8 million for the same period in 2019, primarily reflecting higher sales of Captisol for use with remdesivir. Contract revenue was $9.5 million for the third quarter of 2020, compared with $8.2 million for the same period in 2019.

Cost of goods sold was $6.4 million for the third quarter of 2020, compared with $3.1 million for the same period in 2019, with the increase primarily attributable to higher sales of Captisol. Amortization of intangibles was $3.9 million for the third quarter of 2020, compared with $3.6 million for the same period in 2019, with the increase attributable to the Icagen acquisition in April 2020. Research and development expense was $12.9 million for the third quarter of 2020, compared with $13.7 million for the same period of 2019, with the decrease primarily attributable to amortization of research and development expense related to Novan and Palvella in the prior-year period. General and administrative expense was $15.0 million for the third quarter of 2020, compared with $9.5 million for the same period in 2019, with the increase primarily attributable to additional expenses from Icagen and other acquisition-related cost.

Net loss for the third quarter of 2020 was $6.7 million, or $0.42 per share, compared with net loss of $15.3 million, or $0.81 per share, for the same period in 2019. Net loss for the third quarter of 2020 included a $11.7 million net non-cash loss from the value of Ligand’s short-term investments, while net loss for the third quarter of 2019 included a $13.4 million net non-cash loss from the value of Ligand’s short-term investments. Adjusted net income for the third quarter of 2020 was $17.5 million, or $1.04 per diluted share, compared with $9.5 million, or $0.49 per diluted share, for the same period in 2019. Please see the table below for a reconciliation of net income/(loss) to adjusted net income.

As of September 30, 2020, Ligand had cash, cash equivalents and short-term investments of $795 million. Following the closing of the Pfenex acquisition on October 1, Ligand had approximately $400 million in cash, cash equivalents and short-term investments.

Year-to-Date Financial Results

Total revenues for the nine months ended September 30, 2020 were $116.4 million, compared with $93.3 million for the same period in 2019. Royalties for the nine months ended September 30, 2020 were $22.8 million and primarily consisted of royalties from Kyprolis and EVOMELA. Royalties for the nine months ended September 30, 2019 were $35.9 million and included $14.2 million in royalties from Promacta; Ligand sold its Promacta license to Royalty Pharma as of March 6, 2019. Captisol sales were $69.0 million for the nine months ended September 30, 2020, compared with $24.4 million for the same period in 2019, with the increase primarily reflecting higher sales of Captisol for use with remdesivir. Contract revenue was $24.7 million for the nine months ended September 30, 2020, compared with $33.0 million for the same period in 2019, with the change due to the timing of partner events.

Cost of goods sold was $18.7 million for the nine months ended September 30, 2020, compared with $9.4 million for the same period in 2019, with the increase primarily attributable to higher sales of Captisol. Amortization of intangibles for the nine months ended September 30, 2020 was $11.3 million, compared with $10.6 million for the same period in 2019, with the increase attributable to the Icagen acquisition. Research and development expense was $37.5 million for the nine months ended September 30, 2020, compared with $37.2 million for the same period of 2019. General and administrative expense was $34.4 million for the nine months ended September 30, 2020, compared with $31.6 million for the same period in 2019, with the increase primarily attributable to additional expenses from Icagen and other acquisition-related costs.

Net loss for the nine months ended September 30, 2020 was $8.7 million, or $0.54 per share, compared with net income of $636.7 million, or $31.29 per diluted share, for the same period in 2019. Net loss for the nine months ended September 30, 2020 included a net non-cash loss in the value of Ligand’s short-term investments of $17.9 million, while net income for the same period in 2019 was impacted by an after-tax gain of approximately $643 million on the sale of the Promacta license. Adjusted net income for the nine months ended September 30, 2020 was $49.4 million, or $2.93 per diluted share, compared with $48.2 million, or $2.37 per diluted share, for the same period in 2019. Please see the table below for a reconciliation of net income/(loss) to adjusted net income.

2020 and 2021 Financial Guidance

Ligand reiterates 2020 financial guidance and 2021 financial guidance newly introduced at its Analyst Day event on October 20, 2020, as follows:

For 2020, Ligand expects total revenue to be approximately $170 million and adjusted diluted EPS to be $3.95. Total revenue is expected to consist of $92 million in Captisol sales, $33 million in royalty revenue and $45 million in contract revenue.
For 2021, Ligand expects total revenue to be approximately $285 million and adjusted diluted EPS to be $6.00. Total revenue is expected to consist of $200 million of Captisol sales, $45 million in royalty revenue and $40 million in contract revenue.
Third Quarter 2020 and Recent Business Highlights

OmniAb Platform Updates

OmniAb is Ligand’s multi-species antibody platform for the discovery of mono- and bi-specific therapeutic human antibodies. As of the third quarter of 2020, more than 8,500 clinical subjects have been or are planned to be treated by partners in clinical trials with OmniAb-derived antibodies. New clinical programs are pending at Johnson & Johnson and Merck, among others. Ligand expects the first regulatory submission for OmniAb-derived antibodies in 2021, with potential for as many as 10 approvals expected by 2025.

As part of the OmniAb platform, Ligand recently announced OmniTaur, featuring Ultralong CDR-H3 humanized binding domains recently acquired from Taurus Biosciences. The OmniAb platform also includes the ultra-high resolution, high-speed automated antibody selection technology acquired from xCella Biosciences.

Multiple OmniAb partners reported clinical or regulatory progression with OmniAb-derived antibodies during the third quarter. Additionally, three Ligand partners (Takeda, Immunoprecise and Genovac) are pursuing development of therapeutic antibodies for the treatment of COVID-19 that were discovered with OmniAb.

CStone Pharmaceuticals announced the formation of a $480 million strategic collaboration that encompasses a $200 million equity investment by Pfizer Hong Kong in CStone, collaboration between CStone and Pfizer Investment for the development and commercialization of CStone’s PD-L1 antibody sugemalimab (CS1001) in mainland China and a framework between CStone and Pfizer Investment to bring additional oncology assets to the Greater China market. CStone announced updated results from two clinical studies of sugemalimab at the 2020 Chinese Society of Clinical Oncology Annual Meeting. CStone announced that sugemalimab met the primary endpoint as first-line treatment in stage IV squamous and non-squamous non-small cell lung cancer.

Immunovant announced positive topline results from a multicenter, placebo-controlled Phase 2a trial (ASCEND MG) of IMVT-1401, a novel investigational anti-FcRn antibody delivered by subcutaneous injection, in patients with myasthenia gravis (MG). A registration-enabling Phase 3 MG trial is expected to initiate in the first half of 2021.

Captisol Business Updates

To date in 2020, Ligand has entered into more than 120 Captisol research use agreements and eight clinical and/or commercial license agreements. This is the highest number of use agreements to be signed in a single year since the invention of Captisol.

Captisol is utilized in the formulation of Gilead Sciences’ Veklury (remdesivir), which on October 22, 2020 received U.S. Food and Drug Administration (FDA) approval for the treatment of patients with COVID-19 requiring hospitalization. The product has regulatory approvals for the treatment of moderate or severe COVID-19 in over 50 countries and is included in more than 30 ongoing clinical trials. Ligand is supplying Captisol to Gilead under a recently signed 10-year supply agreement. Ligand is also supplying Captisol to Gilead’s voluntary licensing generic partners who are manufacturing remdesivir for 127 low- and middle-income countries.

Partner Marinus was recently awarded a BARDA contract by the U.S. government to develop Captisol-enabled IV ganaxolone for the treatment of refractory status epilepticus (RSE) caused by nerve agent exposure. Marinus also announced it had satisfied the FDA protocol-specific questions for the registrational Phase 3 trial (the RAISE trial) in RSE, allowing the company to begin patient enrollment in October. Topline data are anticipated in the first half of 2022.

Ligand plans to initiate a potentially pivotal trial for Captisol-enabled Iohexol (CE-Iohexol) in December 2020. CE-Iohexol is an iodine-based contrast agent for hospital-based imaging procedures.

Protein Expression Technology Platform Updates

On October 1, Ligand closed the previously announced acquisition of Pfenex, Inc. Pfenex brings to Ligand a proprietary protein expression technology, as well as major collaborations with Jazz Pharmaceuticals, Merck, Serum Institute of India and Alvogen, each of which has potential to contribute meaningfully to Ligand’s royalty revenue. Our partner Merck announced positive data from two Phase 3 studies with V114, which uses the protein expression technology, evaluating the safety, tolerability and immunogenicity of the investigational 15-valent pneumococcal conjugate vaccine with plans for global regulatory licensure applications in the fourth quarter 2020. Also using the platform, Jazz Pharmaceutical’s Erwinaze supply challenges due to issues with their manufacturer were solved, resulting in a robust process showing manufacturing consistency and efficiency. The program was completed from commencement to projected first BLA filing in approximately four years.

Ligand entered into a new 10-year CRM197 supply agreement with a global multi-national pharmaceutical partner focused on vaccine development.

Other Business Updates

Ligand announced the sale of its Vernalis research operations and internal programs to HitGen Inc. for $25 million in cash. Under the terms of the agreement, Ligand will retain economic rights on completed collaboration licenses as well as a share of the economic rights on current research collaboration contracts. The transaction is expected to close in the fourth quarter of 2020, subject to customary closing conditions.

Several partners also had significant regulatory, financing and business updates during the third quarter: Verona Pharma announced initiation of its ENHANCE Phase 3 trials, Retrophin announced enrollment of the first 280 patients in the pivotal Phase 3 PROTECT study of sparsentan in IgA nephropathy, and Sermonix Pharmaceuticals announced a collaboration with Eli Lilly to study lasofoxifene in combination with Lilly’s CDK 4 and 6 inhibitor abemaciclib in metastatic breast cancer.

Ligand provides regular updates on individual partner events through its Twitter account, @Ligand_LGND.

Adjusted Financial Measures

The Company reports adjusted net income and adjusted net income per diluted share in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company’s financial measures under GAAP include share-based compensation expense, amortization of debt-related costs, amortization related to acquisitions and intangible assets, changes in contingent liabilities, mark-to-market adjustments for amounts relating to its equity investments in public companies, excess tax benefit from share-based compensation, gain on the sale of Promacta and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included at the end of this press release. However, other than with respect to total revenues, the Company only provides financial guidance on an adjusted basis and does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, changes in the market value of its investments in public companies, stock-based compensation expense and effects of any discrete income tax items. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company’s past and future core operating performance. Additionally, adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation.

Conference Call

Ligand management will host a conference call with slides today beginning at 8:30 a.m. Eastern time (5:30 a.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (833) 325-0071 from the U.S. or (720) 405-1612 from outside the U.S., using the conference ID 9279386. To participate via live or replay webcast, a link is available at www.ligand.com. Slides to accompany the conference call are available here.

About OmniAb

OmniAb is a multi-species transgenic-animal platform consisting of six different technologies used for producing mono- and bispecific human therapeutic antibodies. OmniRat animals comprise the industry’s first human monoclonal antibody technology based on rats. Because they have a complete immune system with a diverse antibody repertoire, OmniRat animals generate antibodies with human idiotypes as effectively as wild-type animals make rat antibodies. OmniMouse is a transgenic mouse that complements OmniRat and expands epitope coverage. OmniFlic is an engineered rat with a fixed light chain for development of bispecific, fully human antibodies. OmniChicken animals comprise the industry’s first human monoclonal antibody technology based on chickens. The OmniClic chicken is specifically developed to facilitate the generation of bispecific antibodies and retains the ability to generate diverse, high quality affinity matured antibodies. All five types of OmniAb therapeutic human antibody platform, OmniRat, OmniFlic, OmniMouse, OmniChicken, OmniClic and OmniTaur, use patented technology, have broad freedom to operate, produce highly diversified, fully human antibody repertoires optimized in vivo for immunogenicity, manufacturability, and therapeutic efficacy, and deliver fully human antibodies with high affinity, specificity, expression, solubility and stability – Naturally Optimized Human Antibodies.

About Captisol

Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella, University Distinguished Professor at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Gilead’s VEKLURY, Amgen’s KYPROLIS, Baxter International’s NEXTERONE, Acrotech Biopharma L.L.C.’s and CASI Pharmaceuticals’ EVOMELA, Melinta Therapeutics’ BAXDELA and Sage Therapeutics’ ZULRESSO. There are many Captisol-enabled products currently in various stages of development. Ligand maintains a broad global patent portfolio for Captisol with more than 400 issued patents worldwide relating to the technology (including 37 in the U.S.) and with the latest expiration date in 2033. Other patent applications covering methods of making Captisol, if issued, extend to 2040.

Protein Expression Technology Platform

The Protein Expression Technology is a robust, validated, cost-effective and scalable platform for recombinant protein production, and is especially well-suited for complex, large-scale protein production where traditional systems are not suitable. Multiple global manufacturers have demonstrated consistent success with the platform and the technology is currently out-licensed for numerous commercial and development-stage programs. The versatility of the platform has been demonstrated in the production of enzymes, peptides, antibody derivatives and engineered non-natural proteins. Partners seek the platform as it can contribute significant value to biopharmaceutical development programs by reducing development timelines and costs for manufacturing therapeutics and vaccines. Given pharmaceutical industry trends toward large molecules with increasing structural complexities, the Protein Expression Technology is well positioned to meet these growing needs as the most comprehensive broadly available protein production platform in the industry.

On October 30, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it will report third quarter 2020 financial results and provide a corporate update before market open on Friday, November 6, 2020 (Press release, Jounce Therapeutics, OCT 30, 2020, View Source [SID1234569476]). Jounce Therapeutics’ management team will host a live conference call and webcast at 8:00 a.m. ET.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Conference Call and Webcast
To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 8009939. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.