Astellas Reports Financial Results for FY2017

On April 26, 2018 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas" ) reported the financial results for fiscal year 2017 ending March 31, 2018 ("FY2017") (Press release, Astellas Pharma US, APR 26, 2018, View Source [SID1234525731]).

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"Key global products including XTANDI continued to demonstrate steady growth in FY2017. We also have made continual investments in the creation of future innovation, including the acquisition of Universal Cells, Inc. in February 2018. The additional cell therapy capabilities of Universal Cells, including proprietary Universal Donor Cell technology, enables Astellas to accelerate our innovative research and development focus within cell therapy," said Kenji Yasukawa, Ph.D., president and CEO, Astellas. "We remain committed to creating medical solutions from a multi-dimensional perspective – including disease, biology and modality – to turn innovative science into value for patients."

Sales Highlights
Sales in FY2017 decreased 0.9% compared to those in the previous fiscal year ("year-on-year") to ¥1,300.3 billion due to the impact of certain items such as the transfer of the global dermatology business in April 2016 and the transfer of long-listed products in Japan in April 2017.

Oncology franchise
Sales of XTANDI increased 16.8% year-on-year to ¥294.3 billion. Sales grew steadily in all regions of the world.

Urology OAB franchise
Sales of Betanis / Myrbetriq / BETMIGA increased 27.2% year-on-year to ¥125.7 billion. Sales increased in all regions of the world. Sales of Vesicare, however, decreased 11.9% year-on-year to ¥102.3 billion.

Transplantation franchise
Sales of Prograf increased 6.6% year-on-year to ¥198.5 billion, and continued to grow in EMEA1 and the Asia and Oceania regions.

Other new and key products
In the Japanese market, continued growth was achieved for products such as Celecox for the treatment of inflammation and pain, Symbicort for the treatment of bronchial asthma, Suglat for the treatment of type 2 diabetes, and Cimzia for the treatment of adult patients with rheumatoid arthritis. Meanwhile, we have been working on steadily increasing market penetration for new products Repatha for the treatment of hypercholesterolemia (launched in April 2016) and Linzess for the treatment of irritable bowel syndrome with constipation (launched March 2017). In the Americas, sales of azole antifungal CRESEMBA grew.

Sales by Region2
Sales in Japan and EMEA decreased, while sales in the Americas and the Asia and Oceania increased. As for the Japanese market, sales decreased 15.3% year-on-year to ¥383.4 billion largely due to the impact of transferring 16 long-listed products in April 2017, and the introduction of generics for Micardis for the treatment of hypertension in June 2017. In EMEA, sales decreased due to the continued impact of transferring the dermatology business in April 2016, yet sales increased when excluding this item.

FY2018 Guidance
The forecasts for fiscal year 2018 ending March 31, 2019 ("FY2018") (core basis) are as shown in the following table. The sales forecast is ¥1,278.0 billion (- 1.7% year-on-year). Core operating profit is forecasted at ¥262.0 billion (-2.5% year-on-year). In FY2018, we expect negative impact on sales and profit due to a decreased amount of recognized deferred income following the transfer of the global dermatology business and the transfer of long-listed products in Japan, foreign exchange, and other factors. Despite the negative impact of the NHI drug price revision in Japan and other factors, we are forecasting sales and core operating profit, excluding the factors associated with previously discussed business transfers and the impact of foreign exchange, to remain largely unchanged year-on-year.

Strategic Highlights in FY2017

Astellas continues to create sustainable growth over the mid-to-long term through the pursuit of three main strategies: "Maximizing the Product Value," "Creating Innovation" and "Pursuing Operational Excellence." The company achieved many accomplishments against these strategies as outlined below:

Maximizing the Product Value

Continued to maximize the growth of the Oncology franchise centered on XTANDI and the Urology OAB franchise including Vesicare and Betanis / Myrbetriq / BETMIGA with new launches across various countries and a growth in franchise sales globally.

In January 2018, Amgen Astellas BioPharma K.K. launched sales in Japan of the Repatha SC injection 420 mg Auto Mini Doser, an additional dosage formulation of Repatha.

In November 2017, executed a co-promotion agreement in Japan with MSD K.K. for SUJANU Combination Tablets, a combination drug of the DPP-4 inhibitor sitagliptin phosphate hydrate (JANUVIA Tablets) and Suglat Tablets.

Creating Innovation
The following are highlights of developments with external partners announced during FY2017.

In April 2017, the Alliance Station was opened by Astellas and Kyoto University as part of a new open innovation initiative to develop advanced medical treatments.

In May 2017, completed the acquisition of Ogeda SA in Belgium and gained the NK3 receptor antagonist fezolinetant (ESN364), which is in development for menopause-related vasomotor symptoms.

In May 2017, signed an agreement to broaden the scope of an existing collaborative research agreement with the Institute of Medical Science of the University of Tokyo utilizing the MucoRice rice-based oral vaccine. Furthermore, in December 2017, a collaborative research agreement was signed aiming at the practical application of the rice-based oral vaccine MucoRice-CTB with the Institute of Medical Science of the University of Tokyo, Chiba University, and ASAHI KOGYOSHA CO., LTD.

In October 2017, launched "JOINUS," a new drug discovery program using a drug-repositioning compound library jointly conducted by Astellas, Mitsubishi Tanabe Pharma, and Daiichi Sankyo.

In October 2017, entered into an exclusive worldwide license agreement with Universal Cells Inc. for the worldwide research, development, and commercialization of new cell therapies and acquired Universal Cells Inc. in February 2018.

In November 2017, exercised an exclusive option right to acquire Mitobridge, Inc. and in January 2018, Mitobridge, Inc. became a wholly-owned subsidiary of Astellas.

In February 2018, entered into a global exclusive licensing agreement on development / commercialization of an immunostimulating gene loading oncolytic virus with Tottori University.

The following are the main development advances achieved during FY2017.

In January 2018, filed applications in Europe and the U.S. for approval of an additional indication for non-metastatic castration-resistant prostate cancer based on the results of the Phase 3 PROSPER trial obtained in September 2017. Furthermore, in February 2018, an approval of XTANDI Tablets (additional dosage form) was received in Japan for castration-resistant prostate cancer.

FLT3/AXL inhibitor gilteritinib (ASP2215) was granted Orphan Drug designation in the U.S. in July 2017, in Europe in January 2018, and in Japan in March 2018. Furthermore, gilteritinib received Fast Track Designation in the U.S. in October 2017 for the treatment of adult patients with FLT3 mutation-positive (FLT3mut+) relapsed or refractory acute myeloid leukemia.

In May 2017, MSD K.K filed an application for approval in Japan with regard to the indication of type 2 diabetes for SUJANU Combination Tablets, a combination drug of JANUVIA Tablets and Suglat Tablets. In March 2018, MSD K.K. obtained the approval.

In June 2017, filed an application for approval in the U.S. for the use of mirabegron in combination with solifenacin 5 mg.

In July 2017, filed an application for marketing approval in Japan with regard to fidaxomicin for the treattment of infectious enteritis.

In August 2017, Amgen Astellas BioPharma K.K. obtained approval in Japan for the Repatha SC Injection 420 mg Auto Mini Doser (additional dosage formulation).

In September 2017, filed an application for approval for Linzess in Japan, as an additional indication for chronic constipation.

In November 2017, submitted a new drug application in Japan for a 12-week extended-release formulation of Gonax for the treatment of prostate cancer (additional dosage formulation).

In January 2018, Amgen Astellas BioPharma K.K. submitted an application in Japan for the bispecific CD19-directed CD3 T cell engager antibody construct blinatumomab (AMG103) to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

In January 2018, submitted an application for the additional indication of Suglat for the treatment of type 1 diabetes mellitus in Japan.

In February 2018, obtained approval in Europe for solifenacin (YM905) oral suspension for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 to 18 years.

In March 2018, enfortumab vedotin, an Antibody-Drug Conjugate (ADC), was granted Breakthrough Therapy Designation in the U.S.

Pursuing Operational Excellence
The following are the main operational excellence initiatives engaged during FY2017.

In April 2017, the asset purchase agreement to allow the transfer of 16 long-listed products in Japan to LTL Pharma Co., Ltd. came into effect. In FY2017, the affected products were transferred to LTL Pharma Co., Ltd.

In April 2017, we established a new global function that will manage the respective regional legal functions and intellectual property functions of Japan, the Americas, EMEA, and Asia and Oceania.

In October 2017, transferred to Maruho Co., Ltd. the manufacturing and marketing approvals in Japan for Protopic, a treatment for atopic dermatitis.

Terminated research operations of Agensys, Inc. by March 2018.

[Enhancing and strengthening the corporate governance system]

Resolved at the meeting of the Board of Directors held in January 2018 to transition to a company with an Audit & Supervisory Committee. This results in further enhancing deliberation on matters such as business strategy in the Board of Directors and further strengthening the supervisory functions of the Board of Directors.

The transition is subject to approval at the Company’s 13th Term Annual Shareholders Meeting to be held in June 2018.

Shire Delivers 7% Product Sales Growth and Robust Pipeline Progress in Q1 2018

On April 26,2018 Shire plc (Shire) (LSE: SHP, NASDAQ: SHPG), the leading global biotech company focused on rare diseases, reported unaudited results for the three months ended March 31, 2018 (Press release, Shire, APR 26, 2018, View Source [SID1234525749]).

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Flemming Ornskov, M.D., M.P.H., Shire Chief Executive Officer, commented:

"Shire is off to a good start in 2018 delivering on our key priorities of commercial execution, pipeline progression, debt pay down, and portfolio optimization. We generated product sales growth of 7% in the first quarter reaching $3.6 billion with important contributions from our Immunology franchise, recently-launched products, and international markets. We delivered $1.0 billion in net operating cash flow allowing us to remain on track towards our debt pay down target.

"We continue to advance our innovative pipeline with seven programs in registration including lanadelumab, the first monoclonal antibody being evaluated to prevent hereditary angioedema attacks, with the potential to change the treatment paradigm for this serious and sometimes life threatening rare disease.

"As part of the ongoing review of our portfolio, we recently announced an agreement for the sale of our Oncology franchise for $2.4 billion allowing us to unlock embedded value and sharpen our focus."

Product and Pipeline Highlights

Regulatory updates

Advanced lanadelumab with accelerated approval pathways underway in the U.S. (PDUFA date of August 26, 2018), Europe, and Canada.
Gained FDA acceptance for additional key filings: CINRYZE sBLA for pediatric use, including Priority Review; prucalopride NDA; and Calaspargase Pegol BLA.
Achieved marketing approval of XIIDRA (lifitegrast ophthalmic solution 5%) in Canada and ADYNOVI in E.U.
Obtained Breakthrough Therapy Designation for maribavir for cytomegalovirus (CMV) infection in transplant patients from FDA.
Clinical and business development updates

Agreed to divest Oncology franchise to Servier S.A.S. for $2.4 billion.
Formed pre-clinical research collaboration to evaluate a potential enzyme replacement therapy using NanoMedSyn’s proprietary synthetic derivatives.

1) The Non GAAP financial measures included within this release are explained on pages 26 – 27, and are reconciled to the most directly comparable financial measures prepared in accordance with U.S. GAAP on pages 20 – 22.
(2) In 2018, Shire created two business segments: a Rare Disease division and a Neuroscience division. As a result, Shire now reports its financial results based on these new segments. Segment contribution margin represents total revenue less cost of sales, direct R&D, and direct selling and marketing expenses. Segment contribution margin percentage represents segment contribution margin as a percentage of segment revenue. For further information, refer to Note 3: Segment reporting on page 19.
(3) Diluted weighted average number of ordinary shares of 912.1 million.
(4) Percentage point change (ppc).
(5) Calculated as a percentage of total revenues.

Product sales growth

Achieved product sales growth of 10% in our Rare Disease division, with increases across all franchises on a reported basis, driven by Immunology, Hematology, Internal Medicine, and Ophthalmics.
Delivered growth of recently launched products of 77%, primarily due to ADYNOVATE, CUVITRU, and GATTEX, as well as XIIDRA with script growth of 27% since Q1 2017.
Experienced decline of 2% in product sales in our Neuroscience division due to the genericization of LIALDA in the second half of 2017. Excluding the impact of LIALDA, Neuroscience grew 12%, primarily driven by VYVANSE.
Operating performance

Generated Non GAAP diluted earnings per ADS of $3.86, an increase of 6%, as Q1 2018 benefited from higher product sales and a lower tax rate, which were partially offset by lower gross margins due to Q1 2017 favorability from the timing of changes in the costs to manufacture certain products.
Reported Non GAAP EBITDA margin of 43%, a slight decline from Q1 2017, with continued benefit from operating efficiencies in SG&A offset by lower gross margins as discussed above.
Rare Disease reported contribution margin of $1,367 million, or 48%, and Neuroscience reported contribution margin of $770 million, or 82%.
Strong cash flow

Strong free cash flow enabled an $866 million reduction in Non GAAP net debt during the quarter.
FINANCIAL SUMMARY – FIRST QUARTER 2018 COMPARED TO FIRST QUARTER 2017

Revenues

Delivered total revenues of $3,766 million representing growth of 5%.
Rare Disease product sales increased 10% to $2,719 million (Q1 2017: $2,472 million), with growth across all franchises on a reported basis and growth from recently launched products. Rare Disease product sales also benefited from favorable foreign currency exchange in our international markets.
Neuroscience product sales decreased 2% to $918 million (Q1 2017: $940 million), due to the launch of generic competition for LIALDA in the second half of 2017. Excluding the impact from LIALDA, Neuroscience product sales grew 12%.
Royalties and other revenues decreased 20% to $129 million (Q1 2017: $160 million), primarily due to the reclassification of ADDERALL XR from royalty revenue to product sales and other accounting changes as required under the new revenue accounting standard as well as lower SENSIPAR royalties.
Operating results

Rare Disease contribution margin percentage was approximately 48% (Q1 2017: 51%), a slight decline from the prior year due to lower gross margins on sales, partially offset by lower selling and marketing costs.
Neuroscience contribution margin percentage was flat at 82% (Q1 2017: 82%), as the decline in sales due to LIALDA was offset by lower costs.
Operating income increased 40% to $694 million (Q1 2017: $497 million), primarily due to lower expense related to the unwind of inventory fair value adjustments, partially offset by higher amortization of acquired intangible assets and integration and acquisition costs.
Non GAAP operating income increased 1% to $1,467 million (Q1 2017: $1,454 million), with the benefit of our on-going cost reduction initiatives and operating synergies offset by lower gross margins as Q1 2017 reflected favorability from the timing of changes in the costs to manufacture certain products.
Non GAAP EBITDA margin was slightly down to 43% (Q1 2017: 44%), primarily due to the lower gross margin referred to above offset by ongoing cost reduction initiatives and operating expense synergies.
Earnings per share (EPS)

Diluted earnings per American Depository Share (ADS) increased 47% to $1.81 (Q1 2017: 1.23). The increase was primarily driven by operating income as noted above, combined with lower expense related to the unwind of inventory fair value adjustments.
Non GAAP diluted earnings per ADS increased 6% to $3.86 (Q1 2017: 3.63) as Q1 2018 benefited from higher product sales and a lower tax rate partially offset by a lower gross margin.
Cash flows

Net cash provided by operating activities increased 120% to $1,010 million (Q1 2017: $459 million), driven by improvements in working capital, higher operating profitability, and a favorable comparison period as the Q1 2017 period included a payment of $346 million associated with the settlement of the DERMAGRAFT litigation.
Non GAAP free cash flow increased 272% to $918 million (Q1 2017: $247 million), primarily due to the growth in net cash provided by operating activities noted above and a decrease in capital expenditures.
Debt

Non GAAP net debt as of March 31, 2018 decreased $866 million since December 31, 2017, to $18,203 million (December 31, 2017: $19,069 million). A combination of Shire’s Non GAAP free cash flow and existing cash balances were utilized to repay debt during the quarter. Non GAAP net debt represents aggregate long and short term borrowings of $18,172 million, and capital leases of $350 million, partially offset by cash and cash equivalents of $318 million.
OUTLOOK

Our 2018 guidance, which continues to include our Oncology franchise, remains unchanged. It will be updated to remove the Oncology franchise upon the close of this pending sale later this year. Similarly, our 2020 guidance remains unchanged and will be updated to remove the Oncology franchise upon the close of this pending sale later this year.

The Non GAAP diluted earnings per ADS forecast assumes a weighted average number of 915 million fully diluted ordinary shares outstanding for 2018.

Our U.S. GAAP diluted earnings per ADS outlook reflects anticipated amortization, integration, and reorganization costs.

Risks associated with this outlook include the potential uncertainty resulting from the announcement by Takeda Pharmaceutical Company Limited that it is considering making a possible offer for Shire.

LabCorp Announces Strong 2018 First Quarter Results and Updates 2018 Guidance

On April 25, 2018 LabCorp (or the Company) (NYSE: LH) reported results for the first quarter ended March 31, 2018, and updated 2018 guidance (Press release, LabCorp, APR 25, 2018, View Source;p=RssLanding&cat=news&id=2344448 [SID1234525667]).

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"We delivered another outstanding quarter, with strong results from each of our businesses demonstrating the power of our multi-faceted platform for growth," said David P. King, chairman and CEO. "The Drug Development business had terrific performance, highlighted by organic revenue growth, robust margin improvement, and continued strength in book-to-bill. The Diagnostics business generated industry-leading organic volume growth despite adverse weather, and expanded key partnerships. As we have highlighted, our Diagnostics and Drug Development businesses are individual market leaders and, as an enterprise, we offer a unique ‘beyond-lab, beyond-CRO’ combination to our business partners. We continue to grow as a global leader in life sciences, positioning us to deliver long-term growth and substantial shareholder value."

Adoption of ASC 606

Effective January 1, 2018, the Company adopted the FASB-issued converged standard on revenue recognition (ASC 606), using the full retrospective method. Unless otherwise indicated, all financial results in 2017 and comparisons to financial results in 2017 have been restated in this press release as if the Company had adopted ASC 606 on January 1, 2017. This accounting change affects the Company’s Diagnostics and Drug Development businesses differently, as explained in this press release; for the enterprise, the accounting change increases revenue, lowers earnings, and has no impact on cash flow. Tables comparing the full-year financial results in 2017 as well as the first quarter financial results in 2018 and 2017 under ASC 606 to the Company’s results for the applicable periods under the prior revenue recognition accounting standard (ASC 605) appear at the end of this press release. In addition, the Company furnished a Supplemental Financial Information presentation on Form 8-K dated April 25, 2018, which includes quarterly financial results in 2017 and full-year financial results in 2016 under ASC 606.

Consolidated Results

First Quarter Results

Revenue for the quarter was $2.85 billion, an increase of 18.0% compared to $2.41 billion in the first quarter of 2017. The increase in revenue was due to growth from acquisitions of 13.4%, organic growth of 3.2%, and the benefit from foreign currency translation of approximately 150 basis points.

Operating income for the quarter was $305.4 million, or 10.7% of revenue, compared to $318.1 million, or 13.2%, in the first quarter of 2017. The decrease in operating income and margin were primarily due to higher restructuring charges, special items, and amortization which together totaled $130.3 million in the quarter, compared to $58.6 million during the same period in 2017. This change was primarily due to acquisition-related costs, and the payment of a one-time bonus to non-bonus-eligible employees following the implementation of the Tax Cuts and Jobs Act of 2017 (TCJA). Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $435.7 million, an increase over last year’s $376.7 million primarily due to acquisitions, organic revenue growth, and the Company’s LaunchPad business process improvement initiative. Adjusted operating margin for the quarter was 15.3% of revenue, down from 15.6% in the first quarter of 2017, due to acquisition mix.

Net earnings in the quarter were $173.2 million, compared to $183.0 million in the first quarter of 2017. Diluted EPS were $1.67 in the quarter, a decrease of 4.6% compared to $1.75 in the same period in 2017. Adjusted EPS (excluding amortization, restructuring charges and special items) were $2.78 in the quarter, an increase of 30.5% compared to $2.13 in the first quarter of 2017.

Operating cash flow for the quarter was $154.7 million, compared to $225.9 million in the first quarter of 2017. The reduction in operating cash flow was driven by the one-time bonus payment related to tax reform and higher working capital to support growth, partially offset by higher cash earnings. Capital expenditures totaled $72.5 million, compared to $72.2 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $82.2 million, compared to $153.7 million in the first quarter of 2017.

At the end of the quarter, the Company’s cash balance and total debt were $361.8 million and $6.8 billion, respectively. During the quarter, the Company repurchased $75.0 million of stock representing approximately 0.4 million shares. On April 24, 2018, the board authorized an increase in the Company’s share repurchase program to a total of $1.0 billion.

***

The following segment results have been restated in this press release as if the Company had adopted ASC 606 on January 1, 2017, and exclude amortization, restructuring charges, special items and unallocated corporate expenses.

First Quarter Segment Results

LabCorp Diagnostics

Revenue for the quarter was $1.77 billion, an increase of 8.0% over $1.64 billion in the first quarter of 2017. The increase in revenue was primarily driven by acquisitions, organic volume (measured by requisitions), and the benefit from foreign currency translation of approximately 30 basis points, partially offset by lower Medicare reimbursement as a result of the implementation of the Protecting Access to Medicare Act (PAMA), and the impact from adverse weather. Total volume (measured by requisitions) increased by 6.9%, of which organic volume was 3.0% and acquisition volume was 3.9%. Revenue per requisition increased by 0.7%.

Adjusted operating income (excluding amortization, restructuring charges and special items) for the quarter was $364.0 million, or 20.6% of revenue, compared to $341.8 million, or 20.8%, in the first quarter of 2017. The increase in operating income was primarily due to strong revenue growth, as the negative impact of adverse weather was largely offset by a favorable legal settlement. The decline in operating margin was due to the negative impact from PAMA, partially offset by strong revenue growth.

Covance Drug Development

Revenue for the quarter was $1.08 billion, an increase of 39.3% over $0.77 billion in the first quarter of 2017. The increase was primarily due to acquisitions, as well as organic growth and the benefit from foreign currency translation of approximately 390 basis points.

Adjusted operating income (excluding amortization, restructuring charges and special items) for the quarter was $108.0 million, or 10.0% of revenue, compared to $68.1 million, or 8.8%, in the first quarter of 2017. The increase in operating income was due to organic demand, LaunchPad savings and acquisitions. The Company remains on track to deliver $150 million of net savings from LaunchPad and $30 million of cost synergies from the integration of Chiltern by the end of 2020.

Net orders and net book-to-bill during the trailing twelve months were $4.84 billion and 1.29, respectively. Backlog at the end of the quarter was $9.17 billion, and the Company expects approximately $3.7 billion of this backlog to convert into revenue in the next twelve months.

***

Outlook for 2018

In the following guidance, all financial results in 2017 and comparisons to financial results in 2017 have been restated in this press release as if the Company had adopted ASC 606 on January 1, 2017. The guidance assumes foreign exchange rates effective as of March 31, 2018 for the remainder of the year, and includes capital allocation.

Revenue growth of 10.0% to 12.0% over 2017 revenue of $10.31 billion, which includes the benefit of approximately 90 basis points of foreign currency translation. This is higher than the prior guidance of 9.5% to 11.5% due to strong organic growth, and a favorable change in currency translation.
Revenue growth in LabCorp Diagnostics of 3.5% to 5.5% over 2017 revenue of $6.86 billion, which includes the negative impact of PAMA as well as the benefit of approximately 20 basis points of foreign currency translation. This is higher than the prior guidance of 3.0% to 5.0% primarily due to strong organic growth.
Revenue growth in Covance Drug Development of 21.0% to 25.0% over 2017 revenue of $3.45 billion, which includes the benefit of approximately 230 basis points of foreign currency translation. This is higher than the prior guidance of 20.0% to 24.0% due to a favorable change in currency translation.
Adjusted EPS of $11.30 to $11.70, an increase of approximately 22.2% to 26.5% over 2017 adjusted EPS of $9.25. This guidance is unchanged from prior guidance, but now includes the projected negative impact of $0.20 to $0.30 for the full year in 2018 from ASC 606, offset by strong first quarter results and an improved outlook for the remainder of the year.
Free cash flow (operating cash flow less capital expenditures) of $1.1 billion to $1.2 billion, compared to $1.1 billion in 2017, unchanged from prior guidance.
Use of Adjusted Measures

The Company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted EPS, adjusted operating income, free cash flow, and certain segment information. The Company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the Company’s operational performance. The Company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the Company’s financial results with the financial results of other companies. However, the Company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in the tables accompanying this press release.

The Company today is furnishing a Current Report on Form 8-K that will include additional information on its business and operations. This information will also be available in the investor relations section of the Company’s website at www.labcorp.com. Analysts and investors are directed to the Current Report on Form 8-K and the website to review this supplemental information.

A conference call discussing LabCorp’s quarterly results will be held today at 9:00 a.m. Eastern Time and is available by dialing 844-634-1444 (615-247-0253 for international callers). The access code is 3095857. A telephone replay of the call will be available through May 9, 2018 and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The access code for the replay is 3095857. A live online broadcast of LabCorp’s quarterly conference call on April 25, 2018, will be available at View Source or at View Source beginning at 9:00 a.m. Eastern Time. This webcast will be archived and accessible through April 19, 2019.

Conatus Pharmaceuticals to Report First Quarter 2018 Financial Results

On April 25, 2018 Conatus Pharmaceuticals Inc. (Nasdaq:CNAT) reported that it will report financial results for the first quarter ended March 31, 2018, after the market close on Wednesday, May 2, 2018 (Press release, Conatus Pharmaceuticals, APR 25, 2018, View Source [SID1234525687]). Conatus will host a conference call and audio webcast at 4:30 p.m. Eastern Time on Wednesday, May 2, 2018, to discuss the financial results and provide a corporate update.

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To access the conference call, please dial 877-312-5857 (domestic) or 970-315-0455 (international) at least five minutes prior to the start time and refer to conference ID 5286754. A live and archived audio webcast of the call will also be available in the Investors section of the Conatus website at www.conatuspharma.com.

Syndax Pharmaceuticals Announces Presentations at the 2018 American Society of Clinical Oncology Annual Meeting

On April 25, 2018 Syndax Pharmaceuticals, Inc. ("Syndax," the Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported five poster presentations at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 1-5, 2018 in Chicago, Illinois (Press release, Syndax, APR 25, 2018, View Source [SID1234525705]).

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Presentation Details
Title: ADVL1513: Results of a phase 1 trial of entinostat, an oral histone deacetylase inhibitor, in pediatric patients with recurrent or refractory solid tumors
First Author: Suman Malempati, MD, Oregon Health and Science University
Abstract Number: 10556
Poster Session: Pediatric Oncology
Poster Board: 229
Date and Time: Saturday, June 2, 2018, 8:00-11:30 AM CT, Hall A

Title: ENCORE 601: A phase 2 study of entinostat in combination with pembrolizumab in patients with microsatellite stable metastatic colorectal cancer
First Author: Nilofer Saba Azad, MD, Sidney Kimmel Cancer Center at Johns Hopkins University
Abstract Number: 3557
Poster Session: Gastrointestinal (Colorectal) Cancer
Poster Board: 50
Date and Time: Sunday, June 3, 2018, 8:00-11:30 AM CT, Hall A

Title: Efficacy and safety of entinostat (ENT) and pembrolizumab (PEMBRO) in patients with nonsmall cell lung cancer (NSCLC) previously treated with anti-PD-(L)1 therapy
First Author: Leena Gandhi, MD, PhD, NYU Perlmutter Cancer Center
Abstract Number: 9036
Poster Session: Lung Cancer—Non-Small Cell Metastatic
Poster Board: 359
Date and Time: Sunday, June 3, 2018, 8:00-11:30 AM CT, Hall A

Title: Entinostat in combination with nivolumab for patients with advanced cholangiocarcinoma and pancreatic adenocarcinoma
First Author: Marina Baretti, MD, Sidney Kimmel Cancer Center at Johns Hopkins University
Abstract Number: TPS4151
Poster Session: Gastrointestinal (Noncolorectal) Cancer
Poster Board: 330a
Date and Time: Sunday, June 3, 2018, 8:00-11:30 AM CT, Hall A

Title: Efficacy and safety of entinostat (ENT) and pembrolizumab (PEMBRO) in patients with melanoma progressing on or after a PD-1/L1 blocking antibody
First Author: Sanjiv S. Agarwala, MD, St. Luke’s Hospital
Abstract Number: 9530
Poster Session: Melanoma/Skin Cancers
Poster Board: 357
Date and Time: Monday, June 4, 2018, 1:15-4:45 PM CT, Hall A