Financial Results of Astellas for the First Three Months of FY2022

On August 1, 2022 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, "the Company") reported the financial results for the first three months (April 1, 2022 – June 30, 2022) of the fiscal year 2022 ending March 31, 2023 (FY2022) (Press release, Astellas, AUG 1, 2022, View Source [SID1234617165]).

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1. Qualitative information on consolidated financial results for the first three months of FY2022 Business performance

Consolidated financial results (core basis) in the first three months of FY2022 are shown in the table below. While revenue increased, core operating profit and core profit decreased.

Revenue
-Sales of XTANDI for the treatment of prostate cancer and XOSPATA for the treatment of acute myeloid leukemia continued to grow.
-PADCEV for the treatment of urothelial cancer contributed to revenue growth due to significant expanding of sales in the United States and Japan as well as an increase in the number of countries in which the product was launched in Europe.
-Additionally, the expansion of sales of Betanis / Myrbetriq / BETMIGA for the treatment of overactive bladder ("OAB") and the immunosuppressant agent Prograf as well as the growth of sales of EVENITY for the treatment of osteoporosis in Japan contributed to revenue growth.

Core operating profit / Core profit-Gross profit increased by 11.0% year-on-year to ¥292.9 billion. The cost-torevenue ratio increased by 4.2 percentage points year-on-year to 23.3%, mainly due to the foreign exchange rate impact from the elimination of unrealized profit in intra-group transactions (increase of ¥12.3 billion year-on-year).-Selling, general and administrative expenses increased by 11.9% year-on-year to ¥153.4 billion.

Although expenses decreased as a result of global optimization of personnel aligned with transformation of product portfolio (decrease of approximately ¥3.0 billion year-on-year) and reduction of mature products-related costs (decrease of approximately ¥2.0 billion year-on-year), the total amount increased due to foreign exchange rate impact (increase of ¥16.7 billion year-onyear) and an increase in investment for new product launch readiness (increase of approximately ¥2.0 billion year-on-year). Selling, general and administrative expenses, excluding co-promotion fees of XTANDI in the United States, increased by 7.4% year-on-year to ¥110.3 billion.

-Research and development (R&D) expenses increased by 26.9% year-on-year to ¥74.0 billion. The total amount increased due to foreign exchange rate impact (increase of ¥7.5 billion year-on-year) in addition to one-time expenses recorded during this period, which was included in the full-year forecast.-Amortisation of intangible assets increased by 80.2% year-on-year to ¥10.7 billion.As a result of the above, core operating profit decreased by 12.0% year-on-year to ¥55.3 billion, and core profit decreased by 6.9% year-on-year to ¥45.8 billion.

ZepzelcaTM (lurbinectedin) approved in Qatar for the treatment of metastatic Small Cell Lung Cancer (SCLC)

On August 1, 2022 Immedica Pharma AB reported that the MOPH Pharmacy & Drug Control Department has approved ZepzelcaTM (lurbinectedin) – for the treatment of metastatic Small Cell Lung Cancer (SCLC) (Press release, Immedica Pharma, AUG 1, 2022, View Source [SID1234617182]).

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"We are pleased to bring a new treatment choice to patients in Qatar with relapsed SCLC," said Anders Edvell, CEO at Immedica Pharma. "The Qatar MOPH approval of lurbinectedin underscores its potential to fill an unmet need in the SCLC community."

Immedica has a strategic alliance with Pharma Mar, the biopharma company which has successfully developed lurbinectedin. Both companies are committed to bringing innovative therapies to patients worldwide.

The approval of Zepzelca by Qatar MOPH Pharmacy & Drug Control Department is based on results from an open label, multi-center, single-arm clinical trial in 105 adults with relapsed SCLC1. The data, which appeared in The Lancet Oncology, in the May 2020 issue, showed that in relapsed SCLC, monotherapy with lurbinectedin had an overall response rate of 35% and a median duration of response of 5.3 months according to investigator assessments. The FDA approval is based on the same data.

PerkinElmer Announces Financial Results for the Second Quarter of 2022

On August 1, 2022 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported financial results for the second quarter ended July 3, 2022 (Press release, PerkinElmer, AUG 1, 2022, View Source [SID1234617198]).

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The Company reported GAAP earnings per share from continuing operations of $1.42, as compared to GAAP earnings per share from continuing operations of $2.19 in the same period a year ago. GAAP revenue for the quarter was $1.23 billion, as compared to $1.23 billion in the same period a year ago. GAAP operating income from continuing operations for the quarter was $251 million, as compared to $332 million for the same period a year ago. GAAP operating profit margin was 20.4% as a percentage of revenue, as compared to 27.1% in the same period a year ago.

Adjusted earnings per share from continuing operations for the quarter was $2.32, as compared to $2.83 in the same period a year ago. Adjusted revenue for the quarter was $1.23 billion, as compared to $1.23 billion in the same period a year ago. Adjusted operating income from continuing operations for the quarter was $402 million, as compared to $411 million for the same period a year ago. Adjusted operating profit margin was 32.7% as a percentage of adjusted revenue, as compared to 33.5% in the same period a year ago.

Adjustments for the Company’s non-GAAP financial measures have been noted in the attached reconciliations.

"Our strong performance in the quarter is a testament to our operational and commercial execution as well as our portfolio evolution over the last three years," said Prahlad Singh, president and chief executive officer of PerkinElmer. "With today’s divestiture announcement, we position the company to transform into a pureplay, high growth, high margin life sciences and diagnostics company with even more focus to capitalize on attractive end markets. This transformation will in turn lead to significant financial strength, allowing us to continue to scale and accelerate our innovation investments, which help our customers bridge the chasm from research to clinic, and clinic to cure."

Financial Overview by Reporting Segment for the Second Quarter

Discovery & Analytical Solutions

Second quarter 2022 revenue was $661 million, as compared to $513 million in the same period a year ago. Reported revenue increased 29% and organic revenue increased 13% as compared to the same period a year ago.
Second quarter 2022 operating income from continuing operations was $70 million, as compared to $64 million for the same period a year ago.
Second quarter 2022 adjusted operating income was $178 million, as compared to $101 million for the same period a year ago.
Diagnostics

Second quarter 2022 revenue was $569 million, as compared to $716 million for the same period a year ago. Reported revenue decreased 20% and organic revenue decreased 19% as compared to the same period a year ago.
Second quarter 2022 operating income from continuing operations was $201 million, as compared to $286 million for the same period a year ago.
Second quarter 2022 adjusted operating income was $245 million, as compared to $328 million for the same period a year ago.
Initiates Third Quarter and Raises Full Year 2022 Guidance

For the third quarter of 2022, the Company forecasts revenue of approximately $1.02-1.03 billion and adjusted earnings per share to be in a range $1.40-1.45.

For the full year 2022, the Company now forecasts revenue of $4.60-4.64 billion and adjusted earnings per share of $7.80-7.90.

Guidance for the third quarter and full year is provided on a non-GAAP basis and cannot be reconciled to the closest GAAP measures without unreasonable effort due to the unpredictability of the amounts and timing of events affecting the items the Company excludes from these non-GAAP measures. The timing and amounts of such events and items could be material to the Company’s results prepared in accordance with GAAP.

Announces Agreement with the Intention to Divest Applied, Food, and Enterprise Services Businesses

The Company is also announcing today that it has entered into an agreement with the intention to divest its Applied, Food, and Enterprise Services businesses to New Mountain Capital for a total consideration of $2.45 billion. The transaction is expected to close in the first quarter of 2023, subject to regulatory approvals and other customary closing conditions. Management will provide additional detail regarding this transaction in a separate release and on today’s webcast. A presentation highlighting this transaction will be available on the Investors section of the Company’s website, www.perkinelmer.com.

Webcast Information

The Company will discuss its second quarter 2022 results, its outlook for business trends, and its intended divestiture of its Analytical, Food, and Enterprise Services businesses during a webcast on August 1, 2022, at 8:00 a.m. Eastern Time. A live audio webcast and presentation will be available on the Investors section of the Company’s website, www.perkinelmer.com.

Use of Non-GAAP Financial Measures

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings announcement also contains non-GAAP financial measures. The reasons that we use these measures, a reconciliation of these measures to the most directly comparable GAAP measures, and other information relating to these measures are included below following our GAAP financial statements.

Factors Affecting Future Performance

This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to estimates and projections of future earnings per share, cash flow and revenue growth and other financial results, developments relating to our customers and end-markets, and plans concerning business development opportunities, acquisitions and divestitures. Words such as "believes," "intends," "anticipates," "plans," "expects," "estimates", "projects," "forecasts," "will" and similar expressions, and references to guidance, are intended to identify forward-looking statements. Such statements are based on management’s current assumptions and expectations and no assurances can be given that our assumptions or expectations will prove to be correct. A number of important risk factors could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements. These factors include, without limitation: (1) markets into which we sell our products declining or not growing as anticipated; (2) the effect of the COVID-19 pandemic on our sales and operations; (3) fluctuations in the global economic and political environments; (4) our failure to introduce new products in a timely manner; (5) our ability to execute acquisitions and divestitures, such as the divestiture of the Applied, Food and Enterprise Services businesses, license technologies, or to successfully integrate acquired businesses and licensed technologies into our existing business or to make them profitable, or successfully divest businesses; (6) our ability to compete effectively; (7) fluctuation in our quarterly operating results and our ability to adjust our operations to address unexpected changes; (8) significant disruption in third-party package delivery and import/export services or significant increases in prices for those services; (9) disruptions in the supply of raw materials and supplies; (10) our ability to retain key personnel; (11) significant disruption in our information technology systems, or cybercrime; (12) our ability to realize the full value of our intangible assets; (13) our failure to adequately protect our intellectual property; (14) the loss of any of our licenses or licensed rights; (15) the manufacture and sale of products exposing us to product liability claims; (16) our failure to maintain compliance with applicable government regulations; (17) regulatory changes; (18) our failure to comply with healthcare industry regulations; (19) economic, political and other risks associated with foreign operations; (20) the United Kingdom’s withdrawal from the European Union; (21) our ability to obtain future financing; (22) restrictions in our credit agreements; (23) discontinuation or replacement of LIBOR; (24) significant fluctuations in our stock price; (25) reduction or elimination of dividends on our common stock; and (26) other factors which we describe under the caption "Risk Factors" in our most recent quarterly report on Form 10-Q and in our other filings with the Securities and Exchange Commission. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

Zymeworks Announces Participation in Upcoming Investor Conferences

On August 1, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing next-generation multifunctional biotherapeutics, reported that management will participate in an upcoming investor conference (Press release, Zymeworks, AUG 1, 2022, View Source [SID1234617214]):

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Citi’s 17th Annual BioPharma Conference. Zymeworks will participate in one-on-one meetings and management will participate in a fireside chat on September 7th in Boston, MA.
2022 Wells Fargo Healthcare Conference. Zymeworks will participate in one-on-one meetings and management will participate in a fireside chat on September 8th in Boston, MA.
Morgan Stanley 20th Annual Global Healthcare Conference. Zymeworks will participate in one-on-one meetings on September 13th and 14th in New York, NY.
H.C. Wainwright 24th Annual Global Investment Conference. Zymeworks will virtually participate in one-on-one meetings on September 13th and 14th and will make available a pre-recorded presentation on September 12th.
The presentation and fireside chats will be available on Zymeworks’ website at View Source

Biomea Fusion Reports Second Quarter 2022 Financial Results and Business Highlights

On August 1, 2022 Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported second quarter 2022 financial results and business highlights (Press release, Biomea Fusion, AUG 1, 2022, View Source [SID1234617233]).

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"The team continues to deliver against critical corporate goals as we look to build tremendous value potential for the company in the near and long-term. During the second quarter, we focused specifically on key clinical operations and clinical science activities to support COVALENT-101. Additionally, we continued to design and execute key experiments to support our diabetes effort as we march towards the clinic," said Thomas Butler, Biomea’s Chief Executive Officer and Chairman of the Board. "The scaffold protein menin has many more functional responsibilities than was previously characterized and, thus, is central to multiple disease settings. Moreover, we believe our approach of covalent menin inhibition with BMF-219 offers potential safety, tolerability, efficacy and durability benefits to patients. We are now well positioned to execute a robust clinical development plan for BMF-219, which includes many liquid and solid tumor indications, as well as type 2 diabetes. Beyond menin inhibition, we are advancing toward the clinic with our second IND candidate, BMF-500, a covalent FLT3 inhibitor with best-in-class potential."

Second Quarter 2022 Pipeline Highlights

Cancer

Enrolled first patient with MM in the ongoing first-in-human Phase I clinical trial (COVALENT-101) evaluating BMF-219 in patients with relapsed or refractory acute leukemias, DLBCL, and MM
Presented Trial in Progress posters for COVALENT-101 at multiple prominent oncology conferences in the United States and in Europe
Presented preclinical data in two posters at AACR (Free AACR Whitepaper) 2022 highlighting the impact of BMF-219 on MYC- and KRAS-driven solid tumors. Building on prior data, BMF-219 exhibited robust anti-tumor effect in cell lines and PDX models in DLBCL and MM cell lines
On track to submit IND for BMF-219 in KRAS mutant NSCLC, CRC, and pancreatic ductal adenocarcinoma (PDAC) in the fourth quarter of 2022
Presented preclinical data at ASCO (Free ASCO Whitepaper) 2022 demonstrating BMF-219’s potency in multiple ex vivo tumor models of Chronic Lymphocytic Leukemia (CLL) with varying cytogenetic risk profiles, Rai stages, and resistance to standard-of-care agents indicating broad activity across these models
Announced IND candidate selection, BMF-500, a potential best-in-class oral covalent inhibitor of FLT3, one of the most frequently altered genes in AML and associated with poor prognosis
Diabetes

Presented new preclinical data in two posters at the ADA Scientific Sessions 2022, demonstrating BMF-219’s strong, prolonged glycemic control, insulin sensitization, and hemoglobin A1C (HbA1c) reduction in two preclinical rat models of diabetes while on drug and after washout, outperforming standard-of-care agents
Announced upcoming oral presentations of BMF-219 preclinical data from two animal models of diabetes at the EASD 2022 annual meeting which will include additional data not previously presented at the ADA Scientific Sessions 2022
On track to submit IND for BMF-219 in type 2 diabetes in the second half of 2022
Second Quarter 2022 Financial Results

Net Income/Loss: Biomea reported a net loss attributable to common stockholders of $33.6 million for the six months ended June 30, 2022, compared to a net loss of $14.3 million for the same period in 2021.
R&D Expenses: Research and development expenses were $23.9 million for the six months ended June 30, 2022, compared to $9.0 million for the same period in 2021. The increase of $14.9 million was primarily due to an increase in personnel-related expenses, as well as an increase in preclinical and clinical development costs, including manufacturing and external consulting, related to the Company’s product candidates, BMF-219 and BMF-500.
G&A Expenses: General and administrative expenses were $9.9 million for the six months ended June 30, 2022, compared to $5.3 million for the same period in 2021. The increase of $4.7 million was primarily due to higher personnel-related expenses and other corporate costs to support the Company’s expanding operations as well as additional costs incurred as a public company.
Cash, Cash Equivalents, Restricted Cash, and Investments: As of June 30, 2022, the Company had cash, cash equivalents, restricted cash, and investments of $150.2 million, compared to $175.7 million as of December 31, 2021.