Sanofi H1 2020 business EPS(1) growth of 9.2%(2) driven by transformation

PARIS, July 29, 2020 /PRNewswire/ -- Sanofi (NASDAQ: SNY; EURONEXT: SAN)

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Q2 2020 sales results reflect the strong performance of Dupixent(®) more than offset by COVID-19 related negative effects on Vaccines, General Medicines and CHC

    --  Net sales were EUR8,207million, down 4.9% on a reported basis and a
        decline of 3.4%((2)) at CER.
    --  Specialty Care sales grew 17.4% driven by strong performance of
        Dupixent(®) (+70% to EUR858 million).
    --  Vaccines sales (-6.8%) were affected by global confinements while in
        Southern Hemisphere demand for flu vaccines was strong.
    --  General Medicines sales down 12.7% partly due to confinement related
        deferrals of elective procedures and channel destocking.
    --  CHC sales declined 8.0% reflected unwinding of consumer stocking and
        lower pharmacy traffic as well as Zantac(®) voluntary recall.

Q2 2020 business EPS((1)) benefits from share revaluation gain and effective cost management

    --  Q2 2020 business net income increased 3.6% to EUR1,601 million and 5.6%
        at CER.
    --  Q2 2020 business EPS((1)) was EUR1.28, up 4.8% at CER (EUR1.18 excluding
        revaluation on retained Regeneron shares).
    --  During the first half of 2020, cost savings of EUR990 million((3)) were
        realized.
    --  Q2 2020 IFRS EPS was EUR6.07, reflecting capital gain from sales of
        Regeneron shares.

R&D transformation, milestones and regulatory achievements

    --  Dupixent(®) approved as the first biologic in China for
        moderate-to-severe atopic dermatitis in adults - first prescription on
        July 22.
    --  Dupixent(®) approved for moderate-to-severe atopic dermatitis in
        children (6 to 11 years) in U.S. and positive CHMP opinion in EU.
    --  Sarclisa(®) approved in EU for certain adults with relapsed and
        refractory multiple myeloma.
    --  Pivotal IKEMA study evaluating Sarclisa(®) in relapsed multiple myeloma
        met primary endpoint at first planned interim analysis.
    --  Libtayo(®) demonstrated clinically meaningful and durable responses in
        advanced basal cell carcinoma.
    --  FDA granted priority review to sutimlimab in cold agglutinin disease.
    --  Collaboration agreements with Translate Bio, Kiadis Pharma and Kymera
        Therapeutics.

Full-year 2020 business EPS((1)) guidance revised upward

    --  Sanofi now expects 2020 business EPS((1)) to grow between 6% and 7%((4))
        at CER, barring unforeseen major adverse events. Applying average July
        2020 exchange rates, the currency impact on 2020 business EPS is
        estimated to be between -3% to -4%.

Sanofi Chief Executive Officer, Paul Hudson, commented:

"I'm proud of what the team delivered in the second quarter. Even with some headwinds from the COVID-19 pandemic, we achieved business EPS growth supported by continued outstanding sales from Dupixent(®), a focus on efficiency and smart spending, and the commitment of our people to patients and our strategic priorities. We also met important regulatory milestones, forged new R&D alliances, and accelerated our efforts to develop potential COVID-19 vaccines. With four new appointments, the management team at Sanofi is now complete and together we are focused on delivering our full-year 2020 guidance."


                                                                              Q2 2020                                    Change                                    Change   
            
              H1 2020                 Change       Change
                                                                                                                                                             at CER                                                            at CER



       IFRS net sales reported                                
            EUR8,207m                                        (4.9%)                                    (3.4%)       
            EUR17,180m                      +0.9%        +1.6%



       IFRS net income reported                               
            EUR7,598m                                                                                                
            EUR9,281m              
     
     nm



       IFRS EPS reported                                       
            EUR6.07                                                                                                  
            EUR7.41               
     
     nm



       Free cash flow(5)                                      
            EUR2,010m                                        +56.5%                                                  
            EUR3,568m                     +69.6%



       Business operating income                              
            EUR2,146m                                         +3.3%                                     +5.3%        
            EUR4,683m                      +8.8%        +9.8%



       Business net income(1)                                 
            EUR1,601m                                         +3.6%                                     +5.6%        
            EUR3,521m                      +8.7%        +9.8%



       Business EPS(1)                                         
            EUR1.28                                          +3.2%                                     +4.8%         
            EUR2.81                       +8.1%        +9.2%

    ---                                                                                                                                                                                                                                 ---

                   (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 Appendix10). The consolidated income statement for Q2 2020 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4;
                    (2) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (definition in Appendix 10); (3) Including around EUR110M related to COVID-19; (4) 2019
                    restated business EPS was EUR5.64, reflecting the discontinuation of equity method accounting for Regeneron investment; (5) Free cash flow is a non-GAAP financial measure (definition in
                    Appendix 10).

R&D update((7))

Consult Appendix 7 for full overview of Sanofi's R&D pipeline

Regulatory update

Regulatory updates since April 24, 2020 include the following:

    --  In June, the National Medical Products Administration (NMPA) in China
        approved Dupixent(®) (dupilumab) for the treatment of
        moderate-to-severe atopic dermatitis in adults whose disease is not
        adequately controlled with topical prescription therapies or when those
        therapies are not advisable. The NMPA identified Dupixent(®) as an
        overseas medicine considered urgently needed in clinical practice,
        leading to an expedited review and approval process. Launch in China
        took place on July 22.
    --  In June, the European Commission (EC) approved Sarclisa(®) (isatuximab)
        in combination with pomalidomide and dexamethasone (pom-dex) for the
        treatment of adult patients with relapsed and refractory multiple
        myeloma who have received at least two prior therapies including
        lenalidomide and a proteasome inhibitor and have demonstrated disease
        progression on the last therapy.
    --  The pediatric hexavalent vaccine, Shan 6, was submitted in India in
        June.
    --  In May, the U.S. Food and Drug Administration (FDA) approved
        Dupixent(®) for children aged 6 to 11 years with moderate-to-severe
        atopic dermatitis whose disease is not adequately controlled with
        topical prescription therapies or when those therapies are not
        advisable. Dupixent(®) is the only biologic medicine approved for this
        patient population.
    --  In May, the FDA granted priority review of the Biologics License
        Application (BLA) for sutimlimab for the treatment of hemolysis in adult
        patients with cold agglutinin disease (CAD).
    --  At the end of July 2020, the R&D pipeline contained 83 projects,
        including 33 new molecular entities in clinical development (or that
        have been submitted to the regulatory authorities). 34 projects are in
        phase 3 or have been submitted to the regulatory authorities for
        approval.

Portfolio update

Phase 3:

    --  Results from the phase 3 trial evaluating the investigational enzyme
        replacement therapy, avalglucosidase alfa, were presented in June at a
        Sanofi-hosted scientific session. Avalglucosidase alfa met the primary
        endpoint demonstrating non-inferiority in improving respiratory function
        compared to avalglucosidase alfa (standard of care) in patients with
        late-onset Pompe disease (LOPD). These data will form the basis for
        global regulatory submissions anticipated in the second half of this
        year. The FDA has granted Breakthrough Therapy and Fast Track
        designations to avalglucosidase alfa for the treatment of patients with
        Pompe disease.
    --  Part A of the pivotal phase 3 trial evaluating Dupixent(®) in patients
        12 years and older with eosinophilic esophagitis (EoE) met both of its
        co-primary endpoints, as well as all key secondary endpoints. An ongoing
        Part B portion of the Phase 3 trial evaluates an additional Dupixent(®)
        dosing regimen.
    --  Topline data for a pivotal, single-arm, open-label trial evaluating
        Libtayo(®) (cemiplimab-rwlc), a PD-1 inhibitor, in patients with
        advanced basal cell carcinoma who had progressed on or were intolerant
        to prior hedgehog pathway inhibitor therapy were announced in May.
        Objective responses were seen in 29% of patients with locally advanced
        basal cell carcinoma (BCC) and in a preliminary analysis, objective
        responses were seen in 21% of patients with metastatic BCC.
        Approximately 85% of patients who responded to Libtayo(®) maintained
        their response for at least one year. Sanofi and Regeneron plan
        regulatory submissions in 2020.
    --  The Phase 3 IKEMA trial evaluating Sarclisa(®) (isatuximab) added to
        carfilzomib and dexamethasone met the primary endpoint at its first
        planned interim analysis. These results were presented as late-breaking
        at the EHA25 Virtual Congress in June 2020. Sarclisa(®) added to
        carfilzomib and dexamethasone reduced the risk of disease progression or
        death by 47% compared to standard of care carfilzomib and dexamethasone
        in patients with relapsed multiple myeloma. These interim results will
        form the basis for global regulatory submissions later this year.
    --  A Phase 3 trial comparing Libtayo(®) in monotherapy for first-line
        locally advanced or metastatic non-small cell lung cancer was stopped
        early due to highly significant improvement in overall survival. Libtayo
        decreased the risk of death by 32.4%, compared to platinum doublet
        chemotherapy, in patients that tested positive for PD-L1 in >=50% of
        tumor cells. The data will form the basis of regulatory submissions in
        the U.S. and EU in 2020.
    --  The brain penetrant BTK inhibitor, SAR442168, (collaboration with
        Principia) entered into phase 3 in multiple sclerosis.
    --  Enrollment of the phase 3 evaluating sarilumab (Kevzara(®)) in giant
        cell arteritis and polymyalgia rheumatica have been terminated.

(7) updates since April 24

    --  It has been decided not to pursue the collaboration with Daiichi Sankyo
        on a pediatric pentavalent vaccine in Japan.

Phase 2

    --  New, longer-term data for Libtayo(® )(PD-1 inhibitor) from a pivotal
        phase 2 trial in advanced cutaneous squamous cell carcinoma (CSCC), the
        deadliest non-melanoma skin cancer, were presented during the virtual
        2020 American Society of Clinical Oncology (ASCO) Annual Meeting. These
        results showed durable responses that deepen over time. Across all
        groups combined, complete responses (CR) are now 16%; in the metastatic
        group with the longest follow-up CRs are 20%.
    --  Long term interim data from the phase 2 open label extension study
        exploring the efficacy and safety of fitusiran, an investigational
        once-monthly, subcutaneously administered RNA interference (RNAi)
        therapy for the treatment of hemophilia A and B, with or without
        inhibitors, were shared in June in a late-breaking presentation at the
        World Federation of Hemophilia Virtual Summit. These data reinforce
        fitusiran's potential to restore hemostatic balance and to lower
        annualized bleed rates (ABRs) over a period up to 57 months.
    --  A phase 2 trial in non-small cell lung cancer with anti-CEACAM5
        (SAR408701) and ramucirumab started.
    --  A next generation pneumococcal conjugate vaccine (collaboration with SK)
        entered into phase 2.
    --  Fluzone(®) HD pediatric entered into phase 2.
    --  It has been decided not to pursue the combination of isatixumab and
        cemiplimab in relapsed refractory multiple myeloma due to insufficient
        additional efficacy over isatuximab monotherapy.

Phase 1

    --  The anti-CD38xCD28xCD3 trispecific monoclonal antibody, SAR442257,
        entered into phase 1 in multiple myeloma and Non-Hodgkin lymphoma
    --  BIVV001, a potential new class of factor VIII therapy for patient with
        hemophilia A, demonstrated positive Phase 1 repeat dose study results as
        reported at the World Federation of Hemophilia Virtual Summit earlier
        this month. The Phase 3 study in previously treated hemophilia A
        patients started last year.
    --  SAR442720 (a SHP2 inhibitor, collaboration with Revolution Medicines) in
        combination with pembrolizumab entered into phase 1 for solid tumors.
    --  SAR443122, a RIPK1 inhibitor (collaboration with Denali) dosed its first
        patient in a Phase 1b trial to evaluate the safety and pharmacodynamic
        effects of SAR443122 in patients with severe COVID-19.
    --  Sanofi has discontinued further development of SAR443060, a RIPK1
        inhibitor (collaboration with Denali) in amyotrophic lateral sclerosis
        and multiple sclerosis and alternatively will advance development of
        SAR443820((8)).

Collaboration

    --  On July 9, Kymera Therapeutics Inc. entered into a multi-program
        strategic collaboration with Sanofi to develop and commercialize
        first-in-class protein degrader therapies targeting IRAK4 in patients
        with immune-inflammatory diseases.
    --  On July 8, the exclusive license of Kiadis' previously undisclosed
        K-NK004 program to Sanofi was announced. The agreement covers Kiadis'
        proprietary CD38 knock out (CD38KO) K-NK therapeutic for combination
        with anti-CD38 monoclonal antibodies, including Sarclisa(®).
        Additionally, Sanofi has obtained exclusive rights to use Kiadis' K-NK
        platform for two undisclosed pre-clinical programs.
    --  On June 23, Sanofi Pasteur and Translate Bio, a clinical-stage messenger
        RNA (mRNA) therapeutics company, agreed to expand their existing 2018
        collaboration and license agreement to develop mRNA vaccines for
        infectious diseases.

(8) DNL 788

2020 second-quarter and first-half financial results((9))

Business Net Income((9))

In the second quarter of 2020, Sanofi generated net sales of EUR8,207 million, a decrease of 4.9% and 3.4% at CER. First-half Sanofi sales were EUR17,180 million, an increase of 0.9% and 1.6% at CER.

Second-quarter other revenues decreased 34.4% (down 35.5% at CER) to EUR231 million, reflecting lower VaxServe sales of non-Sanofi products (EUR185 million, down 39.4% at CER). First-half other revenues decreased 14.8% (down 16.9% at CER) to EUR574 million, including lower VaxServe sales of non-Sanofi products (EUR471 million, down 15.3% at CER).

Second-quarter Gross Profit decreased 7.0% to EUR5,778 million (down 6.0% at CER). The gross margin ratio decreased 1.6 percentage points to 70.4% (70.0% at CER) versus the prior year. The negative impact from net price adjustments of Plavix(®) and the Aprovel(®) family in China, U.S. Diabetes net price evolution and Vaccines more than offset the favorable effect from Specialty Care growth and industrial productivity. In the first half, the gross margin ratio decreased 1.0 percentage point to 71.3% (71.0% at CER) versus the prior year.

Research and Development (R&D) expenses decreased 14.8% to EUR1,352 million in the second quarter. At CER, R&D expenses decreased 15.1% reflecting a decline in Diabetes R&D expenses. In the second quarter, the ratio of R&D to sales decreased 1.9 percentage points to 16.5% compared to the prior year. First-half R&D expenses decreased 9.4% to EUR2,692 million (down 10.1% at CER). In the first half, the ratio of R&D to sales decreased 1.8 percentage points to 15.7% compared to the prior year.

Second-quarter selling general and administrative expenses (SG&A) decreased 7.9% to EUR2,265 million. At CER, SG&A expenses were down 7.1%, reflecting smart spending initiatives and the impact of the COVID-19 pandemic. In the second quarter, the ratio of SG&A to sales decreased 0.9 percentage point to 27.6% compared to the prior year. First-half SG&A expenses decreased 4.7% to EUR4,607 million (down 4.6% at CER). In the first half of 2020, the ratio of SG&A to sales was 1.6 percentage points lower at 26.8% compared to the prior year.

Second-quarter operating expenses were EUR3,617 million, a decrease of 10.6% and 10.2% at CER. First-half operating expenses were EUR7,299 million, a decrease of 6.5% and 6.7% at CER.

Second-quarter other current operating income net of expenses was -EUR8 million versus -EUR91 million in the prior year. In 2020, this line included an expense of EUR239 million (versus a EUR159 million expense in the second quarter of 2019) corresponding to the share of profit to Regeneron of the monoclonal antibodies Alliance, reimbursement of development costs by Regeneron and the reimbursement of commercialization-related expenses incurred by Regeneron. Other current operating income net of expenses included a gain of EUR157 million related to a revaluation of retained Regeneron shares in support of the ongoing collaboration with Regeneron. First-half other current operating income net of expenses was -EUR255 million versus -EUR193 million in the first half of 2019.

The share of profit from associates was EUR2 million in the second quarter versus EUR7 million in the second quarter of 2019. Following the sale of its Regeneron stake at the end of May 2020, Sanofi restated its previously reported non-GAAP indicator (Business Net Income) and excluded the effect of equity method of accounting for Regeneron investment in 2019 and Q1 2020. The Q2 2020 business P&L does not include any effect of the equity method of accounting for Regeneron investment in this line. In the first half, the share of profits from associates was EUR11 million versus EUR10 million for the same period of 2019.

In the second quarter and the first half of 2020, non-controlling interests were -EUR9 million and -EUR21 million versus -EUR5 million and -EUR15 million for the same period of 2019, respectively.

Second-quarter business operating income (BOI) increased 3.3% to EUR2,146 million. At CER, BOI increased 5.3%. The ratio of BOI to net sales increased 2 percentage points to 26.1% versus the second quarter of 2019. Over the period, the BOI ratio of segments were 37.4% for Pharmaceuticals (up 6.4 percentage points), 19.0% for Vaccines (down 7.6 percentage points) and 29.8% for CHC (down 10.6 percentage points). First-half business operating income was EUR4,683 million, up 8.8% (up 9.8% at CER) and included EUR990 million of saving initiatives (including around EUR110 million of savings related to COVID-19). In the first half, operational excellence and deprioritized businesses generated savings of EUR320 million and EUR300 million, respectively while smart spending initiatives realized EUR370 million. In the first half of 2020, the ratio of business operating income to net sales increased 2 percentage points to 27.3%.

Net financial expenses were -EUR92 million in the second quarter versus -EUR96 million in the same period of 2019. First-half net financial expenses were -EUR167 million versus -EUR150 million in the first half of 2019.

Second-quarter and first-half effective tax rate was stable at 22.0% versus the prior period. Sanofi continues to expect its effective tax rate to be around 22% in 2020.

Second-quarter business net income((9)) increased 3.6% to EUR1,601 million and increased 5.6% at CER. The ratio of business net income to net sales increased 1.6 percentage points to 19.5% versus the second quarter of 2019. First-half 2020 business net income((9)) increased 8.7% to EUR3,521 million and increased 9.8% at CER. The ratio of business net income to net sales increased 1.5 percentage points to 20.5% versus the first half of 2019.

(9) See Appendix 3 for 2020 second-quarter consolidated income statement; see Appendix 10 for definitions of financial indicators, and Appendix 4 for reconciliation of IFRS net income reported to business net income.

In the second quarter of 2020, business earnings per share((9)) (EPS) increased 3.2% to EUR1.28 on a reported basis and 4.8% at CER. Excluding the gain on the revaluation of the retained Regeneron shares, business EPS was EUR1.18, down 2.4% at CER. The average number of shares outstanding was 1,252.2 million versus 1,248.5 million in the second quarter of 2019.

In the first half of 2020, business earnings per share((9)) was EUR2.81, up 8.1% on a reported basis and up 9.2% at CER. The average number of shares outstanding was 1,251.7 million in the first half of 2020 versus 1,247.2 million in the first half 2019.

Reconciliation of IFRS net income reported to business net income (see Appendix 4)

In the first half of 2020, the IFRS net income was EUR9,281 million. The main items excluded from the business net income were:

    --  An amortization charge of EUR883 million related to fair value
        remeasurement on intangible assets of acquired companies (primarily
        Genzyme: EUR295 million, Bioverativ: EUR170 million, Boehringer
        Ingelheim CHC business: EUR101 million, Aventis: EUR68 million) and to
        acquired intangible assets (licenses/products: EUR44 million). These
        items have no cash impact on the Company.
    --  An impairment of intangible assets of EUR323 million related to several
        projects including Diabetes.
    --  Restructuring costs and similar items of EUR758 million related to
        streamlining initiatives in Europe.
    --  A pre-tax gain of EUR129 million arising from the divestment of
        Seprafilm to Baxter.
    --  A gain of EUR7,225 million related to the sales of the majority of
        Sanofi's Regeneron shares completed on May 29.
    --  A EUR1 million tax effect arising from the items listed above, mainly
        comprising EUR302 million of deferred taxes generated by amortization
        and impairments of intangible assets and EUR232 million associated with
        restructuring costs and similar items and -EUR475 million of tax related
        to the sale of Regeneron shares. (see Appendix 4).
    --  EUR313 million corresponding to the share of income related to equity
        accounting from Regeneron until May 29, 2020. Sanofi non-GAAP indicator
        (Business net income) does not include the share of income related to
        equity accounting since it ceased to be an associate on May 29, 2020.
    --  An income of EUR30 million net of tax related to restructuring costs of
        associates and joint ventures and expenses arising from the impact of
        acquisitions on associates and joint ventures.

Capital Allocation

In the first half of 2020, free cash flow((10)) increased by 69.6% to EUR3,568 million, after net changes in working capital

(-EUR306 million), capital expenditures (-EUR534 million) and other asset acquisitions(1) (-EUR334 million), disposal proceeds(1) (EUR682 million), and payments related to restructuring and similar items (-EUR458 million). Over the period, acquisitions(2) were EUR2,245 million (related to Synthorx) and proceeds from disposals(2) net of tax were EUR10,512 million (related to sales of Regeneron shares). As a consequence, net debt decreased from EUR15,107 million at December 31, 2019, to EUR7,680 million at June 30, 2020 (amount net of EUR15,969 million cash and cash equivalents).

(1 )Not exceeding EUR500 million per transaction.
(2 )Amount of the transaction above EUR500 million per transaction.

(10) non-GAAP financial measure (definition in Appendix 10).

To access the full press release of the 2020 Q2 results, please click here.

Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that COVID-19 will have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. Any material effect of COVID-19 on any of the foregoing could also adversely impact us. This situation is changing rapidly and additional impacts may arise of which we are not currently aware and may exacerbate other previously identified risks. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2019. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Media Relations:
Ashleigh Koss
908-981-8745
Email: Ashleigh.koss@sanofi.com

Investor Relations:
Felix Lauscher
+33 (0)1 53 77 45 45
Email: IR@sanofi.com

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