Lannett Announces Fiscal 2021 First-quarter Financial Results; Affirms Guidance

On November 4, 2020 Lannett Company, Inc. (NYSE: LCI) reported financial results for its fiscal 2021 first quarter ended September 30, 2020 (Press release, Lannett, NOV 4, 2020, View Source [SID1234569893]).

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"We view our fiscal 2021 first quarter net sales of $126 million as a solid achievement, given our current competitive landscape and overall decline of total prescriptions related to the ongoing pandemic," said Tim Crew, chief executive officer of Lannett. "During the quarter, we fully implemented our cost reduction plan that we estimate will lower expenses by approximately $15 million, annually, and launched four new products, including Levothyroxine Sodium Tablets, a meaningful product for us. More recently, we began marketing two additional products, including the exclusive authorized generic of Tirosint (Levothyroxine Sodium Capsules), a medication that complements and expands our thyroid deficiency portfolio of products. Our plans include launching approximately seven more products over the balance of the current fiscal year. Based on the aforementioned, we are affirming our previous guidance for the fiscal 2021 full year.

"At the end of this month, we intend to use a portion of our existing cash to pay down, in full, our Term A Loans. This milestone will lower our annual interest expense and principal payments by approximately $30 million, thus improving our financial flexibility. Moreover, our remaining debt is free of financial covenants and the nearest maturity is in November of 2022, two years away.

"We continue to advance a number of drug candidates in our portfolio that we believe have durable value and the potential to be catalysts for significant growth. Our respiratory and biosimilar product candidates with large addressable markets remain on track, and we expect to expand such durable portfolio assets over the course of this fiscal year."

For the fiscal 2021 first quarter on a GAAP basis, net sales were $126.5 million compared with $127.3 million for the first quarter of fiscal 2020. Gross profit was $25.7 million, or 20% of net sales, compared with $42.7 million, or 33% of net sales. The company recorded restructuring expenses of $4.0 million compared with $1.4 million in the prior-year first quarter. Net loss was $6.5 million, or $0.17 per share, compared with $12.2 million, or $0.32 per share, for the first quarter of fiscal 2020.

For the fiscal 2021 first quarter reported on a Non-GAAP basis, net sales were $126.5 million compared with $127.3 million for the first quarter of fiscal 2020. Adjusted gross profit was $34.4 million, or 27% of net sales, compared with $52.6 million, or 41% of net sales, for the prior-year first quarter. Adjusted interest expense decreased to $11.2 million compared with $15.3 million for the first quarter of fiscal 2020. Adjusted net income was $2.2 million, or $0.06 per diluted share, compared with $8.8 million, or $0.22 per diluted share, for the fiscal 2020 first quarter. Adjusted EBITDA for the fiscal 2021 first quarter was $33.2 million.

Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 4:30 p.m. ET to review its results of operations for its fiscal 2021 first quarter ended September 30, 2020. The conference call will be available to interested parties by dialing 800-447-0521 from the U.S. or Canada, or 847-413-3238 from international locations, passcode 49992942. The call will be broadcast via the Internet at www.lannett.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company’s financial status and performance, regulatory and operational developments, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including Adjusted EBITDA, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). Management uses these measures internally for evaluating its operating performance. The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. The company also believes that including Adjusted EBITDA, as defined in the company’s existing Credit Agreement, is appropriate to provide additional information to investors to demonstrate the company’s ability to comply with financial debt covenants. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP.

Detailed reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures are included with this release.

Non-GAAP financial measures exclude, among others, the effects of (1) amortization of purchased intangibles and other purchase accounting entries, (2) restructuring expenses, (3) non-cash interest expense, as well as (4) certain other items considered unusual or non-recurring in nature.

Adjusted EBITDA excludes the same adjustments discussed above, as well as additional adjustments permitted under the company’s existing Credit Agreement.

Centene To Participate At Upcoming Conferences

On November 4, 2020 Centene Corporation (NYSE: CNC) reported it will participate at two virtual conferences this month (Press release, Centene , NOV 4, 2020, View Source [SID1234569892]).

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On Tuesday, November 10, at 8:45 a.m. Eastern Standard Time (EST), Centene will participate in a virtual format at the Credit Suisse 29th Annual Healthcare Conference. A simultaneous live audio webcast is available at: View Source

The following week, Centene will participate in a virtual format at the Bernstein Operational Decisions Conference on Monday, November 16, at 8:00 a.m. EST. A simultaneous live audio webcast is available at: View Source

Webcast replays will be available afterwards via the Company’s website at www.centene.com under the Investors section.

Protagonist Therapeutics Reports Third Quarter Financial Results and Provides Corporate Update

On November 4, 2020 Protagonist Therapeutics, Inc. (Nasdaq: PTGX) reported its financial results for the third quarter ended September 30, 2020, and provided a corporate update (Press release, Protagonist, NOV 4, 2020, View Source [SID1234569891]).

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"The three clinical assets PTG-300, PN-943 and PTG-200, all discovered through our peptide technology platform, continue to make progress in Phase 2 clinical proof-of-concept studies," commented Dinesh V. Patel, Ph.D., Protagonist President and Chief Executive Officer. "We look forward to sharing updated clinical data in December from our Phase 2 study of PTG-300 in patients with polycythemia vera and see significant opportunity for PTG-300 to address unmet needs and improve upon the current standards of care."

Dr. Patel continued, "We are moving forward with our ongoing Phase 2 clinical programs with the oral alpha-4-beta-7 integrin antagonist PN-943 in patients with ulcerative colitis, and the oral interleukin-23 receptor antagonist PTG-200 in patients with Crohn’s disease. In addition, we’re encouraged by the steady progress in our ongoing collaboration with Janssen, and recently announced the selection of two additional oral interleukin-23 receptor antagonists, PN-235 and PN-232, for advancement into clinical development. These candidates provide several strategic options for development in multiple indications."

Product Development and Corporate Update

PTG-300: Subcutaneous Injectable Hepcidin Mimetic for Polycythemia Vera and Other Blood Disorders

Five presentations have been accepted for the American Society for Hematology (ASH) (Free ASH Whitepaper) Annual meeting, taking place in a virtual format from December 5-8, 2020. Two posters and one oral presentation are related to PTG-300 and polycythemia vera and two posters describe the hepcidin mimetic mechanism of action and a hepcidin mimetic for oral delivery.
In October, PTG-300 was granted orphan designation by the European Medicines Agency for the treatment of polycythemia vera.
Complete enrollment of 50 patients in the PTG-300 polycythemia vera study is expected in mid-2021.
A pivotal study of PTG-300 in the treatment of polycythemia vera is expected to begin in the second half of 2021 pending dialog with regulatory authorities.
An open-label proof-of-concept study of PTG-300 in patients with hereditary hemochromatosis is in progress and results are expected in 2021.
PN-943: Oral Alpha-4-Beta-7 Integrin Antagonist for Inflammatory Bowel Disease

Protagonist has dosed patients in a global, randomized, double-blind, placebo-controlled Phase 2 study (the "IDEAL Study") evaluating safety, tolerability and efficacy of PN-943 in approximately 150 patients with moderate to severe ulcerative colitis.
In light of the global COVID-19 pandemic, Protagonist has suspended guidance on a timeline for study completion.
Oral IL-23 Receptor Antagonists (Janssen Biotech and Protagonist Collaboration)

Protagonist Therapeutics and Janssen Biotech are jointly conducting the development of PTG-200 (JNJ-67864238) through completion of a Phase 2 clinical proof of concept study in the treatment of Crohn’s disease.
Two additional oral peptide IL-23 receptor antagonist candidates from the collaboration agreement with Janssen Biotech, PN-235 (JNJ-77242113) and PN-232 (JNJ-75105186), have been selected for advancement into clinical development. A Phase 1 study of PN-235 is expected to begin in the fourth quarter of 2020.
Financial Update

During the third quarter of 2020, the Company issued 333,000 shares through its at-the-market (ATM) program and raised $6.4 million; shares were sold at an average price of $19.65 per share.
The Company also reported sales of an additional 918,000 shares through its ATM program during October 2020, raising $18.9 million, at an average price of $21.03 per share.
Financial Results

Cash, cash equivalents and marketable securities as of September 30, 2020, were $200.0 million. Protagonist estimates sufficient financial resources from its cash, cash equivalents, marketable securities and access to its debt facility to fund its currently planned operating and capital expenditures through mid-2023.
License and collaboration revenues were $13.1 million and $23.0 million for the three and nine months ended September 30, 2020, respectively, in comparison to $4.1 million and $(2.5) million reported for the same periods of 2019. The increase in revenue in the third quarter of 2020 compared to 2019 was related to an estimate update for services completed versus remaining services to be performed under the Janssen collaboration agreement. This revised estimate accelerated our overall performance percentage completion under the current accounting performance obligation, coupled with continued delivery of Protagonist’s services under the ongoing collaboration. The increase in year-over-year revenue was also related to a previously reported 2019 one-time cumulative adjustment related to the application of revenue recognition principles following the May 2019 amendment of the Janssen Biotech collaboration agreement that had reduced revenue by $9.4 million for the nine months ended September 30, 2019.
Research and Development (R&D) expenses for the three and nine months ended September 30, 2020, were $16.0 million and $55.0 million, respectively, as compared to $17.3 million and $49.1 million for the same periods of 2019. 2020 expenses were primarily related to advancing our clinical development including the ongoing Phase 2 clinical trial for polycythemia vera with PTG-300, PN-943 Phase 2 study in ulcerative colitis, and the IL-23 receptor antagonist research collaboration activities with Janssen Biotech.
General and Administrative (G&A) expenses for the three and nine months ended September 30, 2020, were $4.9 million and $13.6 million, respectively, as compared to $4.0 million and $11.6 million for the same periods of 2019. The increases were primarily related to professional fees, insurance costs and salary related expenses to support the growth in operations.
Net loss for the three and nine months ended September 30, 2020, was $7.8 million and $47.3 million or a net loss of $0.21 per share and $1.45 per share, respectively, as compared to a net loss of $16.4 million and $59.7 million, or a net loss of $0.61 per share and $2.36 per share, respectively, for the same periods of 2019.

Amgen To Present At The 29th Annual Credit Suisse Healthcare Conference

On November 4, 2020 Amgen (NASDAQ:AMGN) reported that it will present at the 29th Annual Credit Suisse Virtual Healthcare Conference at 4:15 p.m. ET on Monday, Nov. 9, 2020, in Scottsdale, Ariz (Press release, Amgen, NOV 4, 2020, View Source [SID1234569890]). Murdo Gordon, executive vice president of Global Commercial Operations at Amgen and Peter H. Griffith, executive vice president and chief financial officer, will present at the conference. Live audio of the presentation can be accessed from the Events Calendar on Amgen’s website, www.amgen.com, under Investors. A replay of the webcast will also be available on Amgen’s website for at least 90 days following the event.

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Innovent and Lilly Jointly Announce Results of Seven Clinical Studies of TYVYT® (sintilimab injection) to Be Presented at the ESMO ASIA Congress 2020

On November 4, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for treatment of oncology, metabolic, autoimmune and other major diseases, and Eli Lilly and Company ("Lilly",NYSE: LLY) reported that results of seven clinical studies of TYVYT (sintilimab injection) will be presented during the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) ASIA ("ESMO ASIA") Virtual Congress 2020 from November 20th to 22nd (Press release, Innovent Biologics, NOV 4, 2020, View Source [SID1234569889]).

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The seven studies of TYVYT (sintilimab injection) to be presented on ESMO (Free ESMO Whitepaper) ASIA include one Proffered Paper Oral Presentation (a Phase 3 study) and six e-posters, covering indications including lung cancer, liver cancer, gastric cancer, and esophageal cancer.

1.
Cancer Type:Liver cancer
Presentation Type:Proffered Paper Oral Presentation
Title: Sintilimab plus bevacizumab biosimilar vs. sorafenib as first-line treatment for advanced hepatocellular carcinoma (ORIENT-32)
Presentation #:523
Presenter:Professor Zhenggang Ren
Date of Presentation: 21 November 2020

2.
Cancer Type:Liver cancer
Presentation Type:E-poster
Title:Sintilimab plus anlotinib as first-line therapy in patients (pts) with advanced hepatocellular carcinoma (aHCC)
Presentation #:170P
Leading PI:Professor Xiaofeng Chen

3.
Cancer Type:Non–Small Cell Lung Cancer
Presentation Type:E-poster
Title: Efficacy and Safety of Sintilimab Plus Docetaxel in Patients with Previously Treated Advanced Non–Small Cell Lung Cancer
Presentation #:402P
Leading PI:Professor Zhehai Wang

4.
Cancer Type:Non–Small Cell Lung Cancer
Presentation Type:E-poster
Title:A Single-Arm Phase Ib Study of Autologous Cytokine-Induced Killer (CIK) Cell Immunotherapy in Combination with Sintilimab plus Chemotherapy in Patients with Advanced Non-Small-Cell Lung Cancer
Presentation #:386P
Leading PI:Professor Xiubao Ren

5.
Cancer Type:Esophageal cancer
Presentation Type:E-poster
Title:A study of neoadjuvant sintilimab combined with triplet chemotherapy of lipo-paclitaxel, cisplatin, and S-1 for resectable esophageal squamous cell carcinoma(ESCC)
Presentation #:175P
Leading PI:Professor Yanhong Gu

6.
Cancer Type:Gastric cancer
Presentation Type:E-poster
Title:Phase II study of sintilimab combined with FLOT regimen for neoadjuvant treatment of gastric or gastroesophageal junction (GEJ) adenocarcinoma
Presentation #:160P
Leading PI: Professor Suxia Luo, Ning Li

7.
Cancer Type:Gastric cancer
Presentation Type:E-poster
Title: Perioperative sintilimab in combination with concurrent chemoradiotherapy for patients with locally advanced gastric or gastroesophageal junction (GEJ) adenocarcinoma
Presentation #:196TiP
Leading PI: Professor Baorui Liu

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after two lines or later of systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT (sintilimab injection) is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL), in November 2019. In April 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with ALIMTA (pemetrexed) and platinum chemotherapy as first-line therapy for the treatment of patients with non-squamous non-small cell lung cancer (NSCLC). In May 2020, TYVYT (sintilimab injection) monotherapy met the primary endpoint of overall survival in the Phase 2 ORIENT-2 study as second-line therapy in patients with advanced or metastatic esophageal squamous cell carcinoma. In August 2020, the NMPA accepted the sNDA for TYVYT (sintilimab injection) in combination with GEMZAR (gemcitabine for injection) and platinum chemotherapy as first-line therapy in squamous NSCLC. In September 2020, TYVYT (sintilimab injection) in combination with BYVASDA (bevacizumab biosimilar injection) as a first-line treatment in advanced hepatocellular carcinoma met the predefined primary endpoints of overall survival and progression-free survival in an interim analysis of the Phase 3 ORIENT-32 study.

TYVYT (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1 / PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies for TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registrational or pivotal clinical trials. Meanwhile, Innovent is conducting clinical research studies on TYVYT (sintilimab injection) worldwide.