Press Release: Strong Q1 growth driven by Specialty Care, Vaccines and CHC

On April 27, 2023 Sanofi reported Strong Q1 growth driven by Specialty Care, Vaccines and CHC (Press release, Sanofi, APR 27, 2023, View Source [SID1234630622]).

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Q1 2023 sales growth of 5.5% at CER and business EPS(1) growth of 11.9% at CER

Specialty Care grew 18.3% driven by Dupixent (€2,316 million, +39.7%) and Rare Disease
Vaccines up 15.2% reflecting recovery of Booster and Travel vaccines and COVID vaccine shipments in Europe
General Medicines sales lower (-11.4%) mainly due to Lantus and divestments, core assets growing 1.6%
CHC sales of €1,495 million increased by 11.2% with price and favorable phasing as main contributors
Business EPS(1) of €2.16 up 11.3% on a reported basis and 11.9% at CER
IFRS EPS of €1.60 (down 0.6%)
Key R&D milestones and regulatory achievements in Q1

ALTUVIIIO approved by the FDA for the treatment of adults and children with hemophilia A
Two additional approvals for Dupixent in Europe (EoE from 12 years and AD in 6 months and older)
Dupixent accepted for review in the U.S. and Japan for the treatment of CSU
Dupixent met primary and all secondary endpoints in its first phase 3 study in patients with COPD
Progress on Corporate Social Responsibility strategy in Q1

Sanofi partnering with Ghana Ministry of Health to improve affordable access to diabetes care
Net Zero(2) by 2045 and updated scope 3 targets validated by Science Based Targets Initiative (SBTi)
Full-year 2023 business EPS guidance confirmed

Sanofi expects 2023 business EPS(1) to grow low single digit(3) at CER, barring unforeseen major adverse events. Applying average April 2023 exchange rates, the currency impact on 2023 business EPS is estimated between -5.5% to -6.5%

Paul Hudson, Sanofi Chief Executive Officer, commented:

"We have started 2023 with strong results, delivering double-digit sales growth across our Specialty Care, Vaccines and Consumer Healthcare businesses. Dupixent continues its compelling performance and is on track to achieve its €10 billion sales objective for this year. The unique product profile of Dupixent was further underscored by highly positive pivotal results in uncontrolled chronic obstructive pulmonary disease, which we are looking forward to discuss with regulators. We are also advancing our early-to-mid stage pipeline and plan to feature several promising candidates at upcoming R&D investor events. For the remainder of the year, we are confident in our business outlook, while navigating the impact from generic versions of Aubagio, our last meaningful patent expiry this decade, with generics entering the U.S. market at the end of Q1. With the U.S. launch of ALTUVIIIO now underway and the anticipated roll-out of Beyfortus in time for the RSV season later this year, we keep executing on our Play to Win growth strategy."

Q1 2023 Change Change
at CER
IFRS net sales reported €10,222m +5.7% +5.5%
IFRS net income reported €1,995m -0.7% _
IFRS EPS reported €1.60 -0.6% _
Free cash flow(4) €1,537m -10.0% _
Business operating income €3,333m +8.7% +9.3%
Business net income(1) €2,699m +11.3% +11.9%
Business EPS(1) €2.16 +11.3% +11.9%
Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 7). (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (definition in Appendix 7). The consolidated income statement for Q1 2023 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) refer to ESG section for Sanofi Net Zero definition; (3) 2022 business EPS was €8.26; (4) Free cash flow is a non-GAAP financial measure (definition in Appendix 7)

Quest Diagnostics Reports First Quarter 2023 Financial Results; Updates Guidance for Full Year 2023

On April 27, 2023 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the first quarter ended March 31, 2023 (Press release, Quest Diagnostics, APR 27, 2023, View Source [SID1234630619]).

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"In the first quarter we delivered double digit year-over-year revenue growth in our base business, driven by strong performance across our physician and hospital customers," said Jim Davis, Chairman, CEO and President. "We are excited about our announced acquisition of Haystack Oncology, which supports our molecular genomics and oncology strategy in the fast growing category of minimal residual disease testing."

Mr. Davis continued: "Our updated guidance reflects continued strong performance in our base business, offset by faster than expected declines in COVID-19 revenues and modest dilution from our planned acquisition of Haystack."

Three Months Ended March 31,

2023

2022

Change

(dollars in millions, except per share data)

Reported:

Net revenues

$ 2,331

$ 2,611

(10.7) %

Base business revenues (a)

$ 2,212

$ 2,012

10.0 %

COVID-19 testing revenues

$ 119

$ 599

(80.2) %

Diagnostic Information Services revenues

$ 2,259

$ 2,541

(11.1) %

Revenue per requisition

(7.7) %

Requisition volume

(3.8) %

Organic requisition volume

(3.9) %

Operating income (b)

$ 305

$ 513

(40.6) %

Operating income as a percentage of net revenues (b)

13.1 %

19.7 %

(6.6) %

Net income attributable to Quest Diagnostics (b)

$ 202

$ 355

(43.0) %

Diluted EPS (b)

$ 1.78

$ 2.92

(39.0) %

Cash provided by operations

$ 94

$ 480

(80.5) %

Capital expenditures

$ 127

$ 63

101.3 %

Adjusted (b):

Operating income

$ 350

$ 554

(36.8) %

Operating income as a percentage of net revenues

15.0 %

21.2 %

(6.2) %

Net income attributable to Quest Diagnostics

$ 232

$ 392

(40.7) %

Diluted EPS

$ 2.04

$ 3.22

(36.6) %

(a)

Excludes COVID-19 testing.

(b)

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

Updated Guidance for Full Year 2023

The company updates its Full Year 2023 guidance as follows:

Updated Guidance

Prior Guidance

Low

High

Low

High

Net revenues

$8.93 billion

$9.08 billion

$8.83 billion

$9.03 billion

Net revenues decrease

(9.6) %

(8.1) %

(10.7) %

(8.6) %

Base business revenues (a)

$8.78 billion

$8.88 billion

$8.65 billion

$8.75 billion

Base business revenues increase

4.2 %

5.4 %

2.6 %

3.8 %

COVID-19 testing revenues

$150 million

$200 million

$175 million

$275 million

COVID-19 testing revenues decrease

(89.7) %

(86.2) %

(88.0) %

(81.1) %

Reported diluted EPS

$7.52

$8.02

$7.61

$8.21

Adjusted diluted EPS

$8.45

$8.95

$8.40

$9.00

Cash provided by operations

At least $1.3 billion

At least $1.3 billion

Capital expenditures

Approximately $400 million

Approximately $400 million

(a) Excludes COVID-19 testing

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, amortization expense, excess tax benefits ("ETB") associated with stock-based compensation, costs associated with donations, contributions, and other financial support through Quest for Health Equity (our initiative with the Quest Diagnostics Foundation to reduce health disparities in underserved communities), gains and losses associated with changes in the carrying value of our strategic investments, and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: 7895081; or via live webcast on our website at www.QuestDiagnostics.com/investor. We suggest participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or, from approximately 10:30 a.m. Eastern Time on April 27, 2023 until midnight Eastern Time on May 11, 2023, by phone at 866-363-1835 for domestic callers or 203-369-0200 for international callers. Anyone listening to the call is encouraged to read our periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

Investor Presentation

On April 27, 2023 PDS Biotechnology presented its investor presentation (Presentation, PDS Biotechnology, APR 27, 2023, View Source [SID1234630618]).

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Outlook Therapeutics® to Present at the H.C. Wainwright BioConnect Investor Conference

On April 27, 2023 Outlook Therapeutics, Inc. (Nasdaq: OTLK), a biopharmaceutical company working to develop and launch the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, reported that Russ Trenary, President and Chief Executive Officer and Glen Olsheim as Executive Director, Commercial Excellence of Outlook Therapeutics will participate in a fireside chat at the H.C. Wainwright BioConnect Investor Conference at Nasdaq on Tuesday, May 2, 2023 at 2:00 PM ET (Press release, Outlook Therapeutics, APR 27, 2023, View Source [SID1234630617]).

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In addition to the presentation, management will be available to participate in one-on-one meetings with qualified members of the investor community who are registered to attend the conference.

A live video webcast of the fireside chat will be accessible on the Events page in the Investors section of the Company’s website (outlooktherapeutics.com). The webcast replay will be archived for 90 days following the event.

Corporate Update

On April 27, 2023 Oncosec Medical presented its corporate presentation (Presentation, OncoSec Medical, APR 27, 2023, View Source [SID1234630616]).

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