On November 8, 2023 Charles River Laboratories International, Inc. (NYSE: CRL) reported its results for the third quarter of 2023 (Press release, Charles River Laboratories, NOV 8, 2023, View Source [SID1234637252]). For the quarter, revenue was $1.03 billion, an increase of 3.8% from $989.2 million in the third quarter of 2022.

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Acquisitions contributed 0.2% to consolidated third-quarter revenue growth. The impact of foreign currency translation benefited reported revenue growth by 1.4%. The divestiture of the Avian Vaccine business in December 2022 reduced reported revenue growth by 1.9%. Excluding the effect of these items, organic revenue growth of 4.1% was driven primarily by the Discovery and Safety Assessment (DSA) and the Research Models and Services (RMS) business segments.

On a GAAP basis, third-quarter net income attributable to common shareholders was $87.4 million, a decrease of 9.4% from $96.5 million for the same period in 2022. Third-quarter diluted earnings per share on a GAAP basis were $1.69, a decrease of 10.1% from $1.88 for the third quarter of 2022. The lower GAAP net income and earnings per share were driven primarily by site consolidation and associated costs, as well as non-operating items, including a loss on certain venture capital and other strategic investments, increased interest expense, and a higher tax rate. GAAP earnings per share included a loss from the Company’s certain venture capital and other strategic investments of $0.11 per share in the third quarter of 2023, compared to a gain of $0.04 per share for the same period in 2022. Certain venture capital and other strategic investment performance has been excluded from the Company’s non-GAAP results.

On a non-GAAP basis, net income was $140.5 million for the third quarter of 2023, an increase of 4.2% from $134.7 million for the same period in 2022. Third-quarter diluted earnings per share on a non-GAAP basis were $2.72, an increase of 3.4% from $2.63 per share for the third quarter of 2022. The non-GAAP net income and earnings per share increases were driven primarily by higher revenue and operating income, partially offset by increased interest expense and a higher tax rate.

James C. Foster, Chairman, President and Chief Executive Officer, said, "We were pleased that our third-quarter financial results exceeded our expectations, and that some early signs of more favorable demand trends began to emerge, such as a sequential improvement in the Safety Assessment cancellation rate. However, we also experienced continued pressure from current client spending patterns, which began to have a discernable impact on the RMS segment and our Microbial Solutions business in the third quarter."

"We believe our business model is resilient, and will benefit from our efforts to ensure that our cost structure remains aligned with the current pace of demand. We remain guided by the imperatives that differentiate us: Strengthening our unique portfolio, enhancing our scientific expertise, providing outstanding client service, and driving greater operating efficiencies. In this market environment, we will focus on market share and our unique role in the drug discovery and non-clinical development process to further distinguish ourselves. We believe this will increasingly enable clients to choose to partner with Charles River to derive additional value through our flexible and efficient outsourcing solutions," Mr. Foster concluded.

Third-Quarter Segment Results

Research Models and Services (RMS)

Revenue for the RMS segment was $186.8 million in the third quarter of 2023, an increase of 3.7% from $180.1 million in the third quarter of 2022. The impact of foreign currency translation benefited revenue by 0.5% in the quarter. Organic revenue growth of 3.2% was primarily driven by research model services, particularly the Insourcing Solutions (IS) business. Revenue growth for small research models in all geographic regions also contributed, principally driven by increased pricing. This was partially offset by lower revenue growth in the Cell Solutions business and the timing of large research model shipments within China.

In the third quarter of 2023, the RMS segment’s GAAP operating margin decreased to 15.2% from 19.9% in the third quarter of 2022, and on a non-GAAP basis, the operating margin decreased to 18.9% from 23.5%. The GAAP and non-GAAP operating margin decreases were driven primarily by the revenue mix and reduced operating leverage from lower revenue growth, as well as the timing of large model shipments within China.

Discovery and Safety Assessment (DSA)

Revenue for the DSA segment was $664.0 million in the third quarter of 2023, an increase of 7.2% from $619.5 million in the third quarter of 2022. The impact of foreign currency translation benefited revenue by 1.5%, and the SAMDI Tech acquisition contributed 0.4% to reported DSA revenue growth in the quarter. Organic revenue growth of 5.3% was driven by the Safety Assessment business, primarily as a result of higher pricing and increased study volume.

In the third quarter of 2023, the DSA segment’s GAAP operating margin decreased to 22.1% from 22.9% in the third quarter of 2022. The decrease in the GAAP operating margin was primarily attributable to site consolidation, impairment, and associated costs related to the closure of a small Discovery Services site in California. On a non-GAAP basis, the operating margin increased to 27.2% from 26.2% in the third quarter of 2022. The non-GAAP operating margin improvement was primarily driven by operating leverage from higher revenue in the Safety Assessment business.

Manufacturing Solutions (Manufacturing)

Revenue for the Manufacturing segment was $175.7 million in the third quarter of 2023, a decrease of 7.3% from $189.6 million in the third quarter of 2022. The impact of the Avian Vaccine divestiture reduced revenue by 9.9%. The impact of foreign currency translation benefited revenue by 1.7% in the quarter. Organic revenue growth of 0.9% reflected higher revenue in the CDMO business, which was almost entirely offset by lower revenue in the Biologics Testing Solutions and Microbial Solutions businesses.

In the third quarter of 2023, the Manufacturing segment’s GAAP operating margin decreased to 15.0% from 16.6% in the third quarter of 2022, and on a non-GAAP basis, the operating margin decreased to 24.5% from 28.6% in the third quarter of 2022. The GAAP and non-GAAP operating margin declines were driven by each of the Manufacturing segment’s businesses.

Updates 2023 Guidance

The Company is updating its 2023 financial guidance, which was previously provided on August 9, 2023. As it moves into the fourth quarter, the Company is narrowing its revenue growth and non-GAAP earnings per share ranges. The updates principally reflect a shift in the gating of the financial results in the second half of the year, as demonstrated by the third-quarter financial performance that exceeded the Company’s prior expectations.

The Company’s 2023 guidance for revenue growth and earnings per share is as follows:

2023 GUIDANCE

CURRENT

PRIOR

Revenue growth, reported

2.5% – 3.5%

2.5% – 4.5%

Impact of divestitures/(acquisitions), net

~1.5%

~1.5%

Impact of 53rd week in 2022

~1.5%

~1.5%

Unfavorable/(favorable) impact of foreign exchange

0.0% – (0.5)%

0.0% – (0.5)%

Revenue growth, organic (1)

5.5% – 6.5%

5.5% – 7.5%

GAAP EPS estimate

$7.30 – $7.50

$7.60 – $8.20

Acquisition-related amortization

$2.00 – $2.05

~$2.00

Acquisition and integration-related adjustments (2)

~$0.25

$0.20 – $0.25

Costs associated with restructuring actions (3)

$0.30 – $0.35

~$0.10

Certain venture capital and other strategic investment losses/(gains), net (4)

$0.18

$0.06

Other items (5)

~$0.40

~$0.30

Non-GAAP EPS estimate

$10.50 – $10.70

$10.30 – $10.90

Footnotes to Guidance Table:

(1) Organic revenue growth is defined as reported revenue growth adjusted for completed acquisitions and divestitures, the 53rd week in 2022, and foreign currency translation.

(2) These adjustments are related to the evaluation and integration of acquisitions and divestitures, and primarily include transaction, advisory, certain third-party integration costs, and certain costs associated with acquisition-related efficiency initiatives.

(3) These adjustments primarily include site consolidation, severance, impairment, and other costs related to the Company’s restructuring actions.

(4) Certain venture capital and other strategic investment performance only includes recognized gains or losses on certain investments. The Company does not forecast the future performance of these investments.

(5) These items primarily relate to charges associated with U.S. and international tax legislation that necessitated changes to the Company’s international financing structure; and certain third-party legal costs related to (a) environmental litigation related to the Microbial Solutions business and (b) investigations by the U.S. government into the NHP supply chain related to our Safety Assessment business.

Webcast

Charles River has scheduled a live webcast on Wednesday, November 8th, at 8:30 a.m. ET to discuss matters relating to this press release. To participate, please go to ir.criver.com and select the webcast link. You can also find the associated slide presentation and reconciliations of GAAP financial measures to non-GAAP financial measures on the website.

On November 8, 2023 BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a commercial-stage biopharmaceutical company focused on genetic diseases and cancers, reported that on November 07, 2023, the compensation committee of BridgeBio’s board of directors granted thirty-three new employees restricted stock units for an aggregate of 183,533 shares of the Company’s common stock (Press release, BridgeBio, NOV 8, 2023, View Source [SID1234637251]). One-fourth of the shares underlying each employee’s restricted stock units will vest on November 16, 2024, with one-twelfth of the remaining shares underlying each such employee’s restricted stock units vesting on a quarterly basis thereafter, in each case, subject to each such employee’s continued employment with the Company or one of its subsidiaries on such vesting dates. All of the above-described awards were made under BridgeBio’s Amended and Restated 2019 Inducement Equity Plan (the "Plan").

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The above-described awards were each granted as an inducement material to the employees entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4) and were granted pursuant to the terms of the Plan. The Plan was adopted by BridgeBio’s board of directors in November 2019 and amended and restated on February 10, 2023.

On November 8, 2023 Biogen Inc. (NASDAQ: BIIB) reported third quarter 2023 financial results (Press release, Biogen, NOV 8, 2023, View Source [SID1234637250]). Commenting on the quarter, President and Chief Executive Officer Christopher A. Viehbacher said:

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"We believe we have the key elements in place to position Biogen for long-term sustainable growth. Biogen has made significant progress on the business priorities outlined at the beginning of the year. During the third quarter alone, we received FDA approval for LEQEMBI and ZURZUVAE, announced the closing of the Reata transaction, and initiated our $1 billion Fit for Growth cost savings program. As we look ahead, the focus remains on execution. We aim to further our leadership in Alzheimer’s disease by both driving the LEQEMBI launch and advancing development of our tau-directed ASO, where we have the potential to establish another foothold in the fight against Alzheimer’s disease. In addition to potential revenue and EPS growth from new launches, Fit for Growth is expected to significantly strengthen our bottom line growth."
Financial Highlights
Q3 ’23 Q3 ’22 △
r (CC#)
Total Revenue (in millions)*
$2,530 $2,508 1% 3%
GAAP diluted EPS $(0.47) $7.84 (106)% —%
Non-GAAP diluted EPS $4.36 $4.77 (9)% —%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period.
* Beginning in the third quarter of 2023, we modified our presentation of the commercialization expenses incurred within the LEQEMBI Collaboration. Our 50% portion of LEQEMBI product revenue, net and cost of sales, including royalties, will continue to be classified as a component of revenue. We will now present our 50% share of all global pre- and post-commercialization sales & marketing expenses for the LEQEMBI Collaboration within SG&A expense and will no longer present the post-commercialization portion of these expenses as a reduction to revenue. To reflect this modification, during the third quarter of 2023 we reclassified $38.7 million in collaboration costs (from the first and second quarters of 2023) from revenue from LEQEMBI Collaboration to SG&A expense within our condensed consolidated statements of income.

# Percentage changes in revenue growth at constant currency (CC) are presented excluding the impact of changes in foreign currency exchange rates and hedging gains or losses. The current period’s foreign currency revenue values are converted into U.S. dollars using the average exchange rates from the prior period.

A reconciliation of GAAP to Non-GAAP financial measures can be found in Table 4 at the end of this news release.
Revenue Summary
(in millions) Q3 ’23 Q3 ’22 △
r (CC#)
Multiple sclerosis (MS) product revenue(1)
$1,159 $1,340 (14)% (12)%
Spinal muscular atrophy revenue(2)
$448 $431 4% 7%
Biosimilars revenue $194 $188 4% 7%
Other product revenue(3)
$4 $3 25% 23%
Total product revenue $1,805 $1,962 (8)% (6)%
Revenue from anti-CD20 therapeutic programs $421 $417 1% 1%
Contract manufacturing, royalty and other revenue(4)
$304 $130 135% 135%
Total revenue $2,530 $2,508 1% 3%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period. Numbers may not foot or recalculate due to rounding.
(1) MS includes TECFIDERA, VUMERITY, AVONEX, PLEGRIDY, TYSABRI and FAMPYRATM.
(2) Spinal muscular atrophy includes SPINRAZA.
(3) Other includes ADUHELM, FUMADERMTM and QALSODY.
(4) Also includes Biogen’s 50% share of revenue, net cost of sales, including royalties, from the LEQEMBI Collaboration and revenue from manufacturing of LEQEMBI beginning in the first quarter of 2023. Beginning in the third quarter of 2023, we modified our presentation of the commercialization expenses incurred within the LEQEMBI Collaboration. Our 50% portion of LEQEMBI product revenue, net and cost of sales, including royalties, will continue to be classified as a component of revenue. We will now present our 50% share of all global pre- and post-commercialization sales & marketing expenses for the LEQEMBI Collaboration within SG&A expense and will no longer present the post-commercialization portion of these expenses as a reduction to revenue. To reflect this modification, during the third quarter of 2023 we reclassified $38.7 million in collaboration costs (from the first and second quarters of 2023) from revenue to SG&A expense within our condensed consolidated statements of income.
•Third quarter 2023 in-market product revenue for LEQEMBI recorded by Eisai was approximately $2 million.
Expense Summary
(in millions) Q3 ’23 Q3 ’22 △
GAAP and Non-GAAP cost of sales*
$660 $470 (40)%
% of Total Revenue 26% 19%
GAAP R&D expense $736 $549 (34)%
Non-GAAP R&D expense $539 $549 2%
GAAP SG&A expense#
$788 $563 (40)%
Non-GAAP SG&A expense#
$553 $562 2%

Note: Percent changes represented as favorable/(unfavorable) versus the prior year period
*Excluding amortization and impairment of acquired intangible assets
# As referenced above, beginning in the third quarter of 2023, our 50% share of all global pre- and post-commercialization sales & marketing expenses for the LEQEMBI Collaboration will be presented within SG&A expense and will no longer present the post-commercialization portion of these expenses as a reduction to revenue. During the third quarter of 2023 we reclassified $38.7 million in collaboration costs (from the first and second quarters of 2023) from revenue to SG&A expense within our condensed consolidated statements of income.

•Third quarter 2023 GAAP and Non-GAAP cost of sales includes approximately $35 million of idle capacity charges. Third quarter 2022 GAAP and Non-GAAP cost of sales includes approximately $11 million of idle capacity charges. The increase in third quarter 2023 GAAP and Non-GAAP cost of sales as a percentage of total revenue was driven primarily by product mix, particularly the year-over-year increase in contract manufacturing revenue.

•The increase in GAAP R&D and SG&A expense in the third quarter of 2023, as compared to the third quarter of 2022, of approximately $187 million and $225 million, respectively, was primarily due to acquisition related charges incurred in connection with our recent acquisition of Reata, including of stock-based compensation expense associated with the accelerated vesting of stock options previously granted to Reata employees.

•Third quarter 2023 GAAP and Non-GAAP R&D expense includes approximately $44 million related to Biogen’s portion of R&D expense related to the LEQEMBI Collaboration, and approximately $37 million in close out costs relating to the EMBARK trial for ADUHELM.

•Third quarter 2023 GAAP and Non-GAAP SG&A includes approximately $82 million related to Biogen’s portion of SG&A expense related to the LEQEMBI Collaboration, which includes a reclassification of $38.7 million in collaboration costs from the first and second quarters of 2023 from revenue to SG&A expense.

•Third quarter 2023 GAAP restructuring expense was $76 million.

•Third quarter 2023 GAAP transaction and integration costs related to the acquisition of Reata was approximately $30 million.
Other Financial Highlights

•Third quarter 2023 GAAP and Non-GAAP collaboration profit sharing was a net expense of $51 million, which includes $56 million of net profit sharing expense related to Biogen’s collaboration with Samsung Bioepis, partially offset by net reimbursement of $6 million from Sage Therapeutics related to the commercialization of ZURZUVAE in the U.S.

•Third quarter 2023 GAAP other expense was $300 million, primarily driven by net unrealized loss on strategic equity investments of $302 million. Third quarter 2023 Non-GAAP other income was $26 million, primarily driven by net interest income.

•Third quarter 2023 GAAP income tax benefit was $73 million, corresponding to an effective tax rate of 51.6%, as compared to an expense of $236 million, or 17.2%, in the third quarter of 2022. The third quarter 2023 GAAP tax benefit was driven by the non-cash changes in the value of Biogen’s equity investments and expenses related to the Reata acquisition. Third quarter 2023 Non-GAAP income tax expense was $100 million, or 14.7%, as compared to an expense of $129 million, or 15.7%, in the third quarter of 2022.
Financial Position

•Third quarter 2023 net cash flow from operations was $592 million. Capital expenditures were $74 million, and free cash flow, defined as net cash flow from operations less capital expenditures, was $518 million.

•As of September 30, 2023, Biogen had cash, cash equivalents, and marketable securities totaling $2,288 million and $7,286 million in total debt, resulting in net debt of $4,998 million.

•No shares of the Company’s common stock were repurchased in the third quarter of 2023. As of September 30, 2023, there was $2,050 million remaining under the share repurchase program authorized in October 2020.

•For the third quarter of 2023 the Company’s GAAP weighted average diluted shares were 145 million. Third quarter 2023 Non-GAAP weighted average diluted shares were 146 million.

3

Full Year 2023 Financial Guidance

For the full year 2023, Biogen is updating its guidance ranges to reflect the completed acquisition of Reata and its previously projected dilution to 2023 Non-GAAP diluted EPS, regulatory approval for ZURZUVAE in PPD, and the modification made to our presentation of LEQEMBI expenses.
Prior FY 2023 Guidance Updated FY 2023 Guidance
Total revenue Mid-single digit percentage decline versus reported full year 2022
Low-single digit percentage decline versus reported full year 2022
Non-GAAP diluted EPS $15.00 to $16.00
$14.50 to $15.00 Reflecting ~$0.75 of dilution from Reata acquisition which closed September 26, 2023

This guidance assumes that foreign exchange rates as of September 30, 2023, will remain in effect for the remainder of the year, net of hedging activities.

This financial guidance does not include any impact from potential acquisitions or large business development transactions or pending and future litigation, as all are hard to predict, or any impact of potential tax or healthcare reform. Biogen may incur charges, realize gains or losses, or experience other events or circumstances in 2023 that could cause any of these assumptions to change and/or actual results to vary from this financial guidance.

Biogen does not provide guidance for GAAP reported financial measures (other than revenue) or a reconciliation of forward-looking Non-GAAP financial measures to the most directly comparable GAAP reported financial measures because the Company is unable to predict with reasonable certainty the financial impact of items such as the transaction, integration, and certain other costs related to acquisitions or large business development transactions; unusual gains and losses; potential future asset impairments; gains and losses from our equity security investments; and the ultimate outcome of pending or future significant litigation without unreasonable effort. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results for the guidance period. For the same reasons, the Company is unable to address the significance of the unavailable information, which could be material to future results.

Conference Call and Webcast

The Company’s earnings conference call for the third quarter will be broadcast via the internet at 8:00 a.m. ET on November 8, 2023 and will be accessible through the Investors section of Biogen’s website, www.biogen.com. Supplemental information in the form of a slide presentation is also accessible at the same location on the internet and will be subsequently available on the website for at least 90 days.

On November 8, 2023 Bicara Therapeutics, a clinical-stage biotechnology company developing dual-action biologics designed to modulate the tumor microenvironment to elicit a potent and durable anti-tumor response, reported that company leadership will present at two upcoming investor conferences in November (Press release, Bicara Therapeutics, NOV 8, 2023, View Source;utm_medium=rss&utm_campaign=bicara-therapeutics-to-present-at-upcoming-november-investor-conferences-2 [SID1234637249]):

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Stifel 2023 Healthcare Conference on Wednesday, November 15 at 9:10 a.m. ET in New York, NY.
Piper Sandler 35th Annual Healthcare Conference on Thursday, November 30 at 12:30 p.m. ET in New York, NY.

On November 8, 2023 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported that the Company will participate in the Jefferies London Healthcare Conference on Wednesday, November 15th, 2023 with a fireside chat at 2:00 pm GMT (Press release, BeiGene, NOV 8, 2023, View Source [SID1234637248]).

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A live webcast of this event can be accessed from the investors section of BeiGene’s website at View Source, View Source, View Source Archived replays will be available for 90 days following the event.