COLOGUARD® REVENUE AND COMPLETED TESTS INCREASED 87 PERCENT TO $90.3 MILLION AND 186,000

On April 26, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $90.3 million and completed approximately 186,000 Cologuard tests during the quarter ended Mar. 31, 2018 (Press release, Exact Sciences, APR 26, 2018, View Source [SID1234525759]). First-quarter 2018 revenue and Cologuard test volume both grew 87 percent from 2017.

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Exact Sciences Corporation Logo (PRNewsfoto/EXACT SCIENCES CORP)

"The Exact Sciences team delivered strong growth to start the year by remaining relentlessly focused on our core priorities. By increasing awareness and adoption of Cologuard, we are making strides toward our mission of playing a role in the eradication of colon cancer," said Kevin Conroy, chairman and CEO of Exact Sciences. "The success of Cologuard also positions us to develop tests that facilitate the early, accurate detection of other forms of cancer."

First-Quarter 2018 Financial Results

For the three-month period ended Mar. 31, 2018, as compared to the same period of 2017 (where applicable):

Revenue was $90.3 million, an increase of 87 percent, and test volume was 186,000, an increase of 87 percent
Average recognized revenue per test was unchanged at $485; note that the prior period included approximately $4.3 million, or $43 per test, related to the one-time impact of certain payers meeting the company’s revenue recognition criteria for accrual-basis revenue accounting
Average cost per test was $123, an improvement of 28 percent
Gross margin was 75 percent, an increase of 970 basis points
Operating expenses were $103.9 million, an increase of 55 percent
Net loss was $39.4 million or $0.33 per share, compared to $34.9 million or $0.32 per share
Non-cash interest expense related to convertible debt was $5.1 million, or $0.04 per share
Cash utilization was $53.7 million, compared to $36.4 million
Cash, cash equivalents and marketable securities were $1.0 billion at the end of the quarter
Nearly 9,000 healthcare providers ordered their first Cologuard test during the first quarter, and 110,000 (rounded) have ordered since the test was launched
2018 Outlook

The company continues to anticipate revenue of $420-$430 million and completed Cologuard test volume of 900,000-920,000 tests during 2018
For the second quarter, the company anticipates completing 220,000-230,000 Cologuard tests
The company’s guidance for revenue and completed tests are forward-looking statements. They are subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projections. See the cautionary information about forward-looking statements in the "Safe Harbor Statement" section of this press release.

First-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Thursday, Apr. 26, 2018, at 5 p.m. ET to discuss first-quarter 2018 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-201-0168 and international callers should dial +1-647-788-4901.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 8289286. The webcast, conference call and replay are open to all interested parties.

About Cologuard

Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2014) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy. Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

Vical Announces News Release and Conference Call Schedule for First Quarter 2018 Financial Results

On April 26, 2018 Vical Incorporated (Nasdaq:VICL) reported that the company will report financial results for the three months ended March 31, 2018, before the opening of trading on Thursday, May 3, and conduct a conference call and webcast to discuss the financial results and provide a company update at noon Eastern Time on Thursday, May 3 (Press release, Vical, APR 26, 2018, View Source [SID1234525758]). The call will be open on a listen-only basis to any interested parties. The company will also provide a business update, including details on development programs in the conference call and webcast.

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Conference Call
To listen to the conference call, dial in approximately ten minutes before the scheduled call to (323) 794-2567 (preferred), or (888) 278-8469 (toll-free), and reference confirmation code 1443635. A replay of the call will be available for 48 hours beginning about two hours after the call. To listen to the replay, dial (719) 457-0820 (preferred) or (888) 203-1112 (toll-free) and enter replay passcode 1443635. The call also will be available live and archived through the events page at www.vical.com.

Invited participants may ask questions during the conference call. Others may submit questions before the call by e-mail addressed to [email protected] or by fax to (858) 646-1150. Submitted questions will be screened for appropriateness and general interest. Selected questions received with sufficient notice before the call will be answered as time permits at the end of the call. For further information, contact Vical’s Investor Relations department by phone at (858) 646-1127 or by email at [email protected].

West Announces First-Quarter 2018 Results

On April 26, 2018 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the first-quarter 2018 and reaffirmed financial guidance for full-year 2018 (Press release, West Pharmaceutical Services, APR 26, 2018, View Source;p=RssLanding&cat=news&id=2344775 [SID1234525757]).

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(PRNewsfoto/West Pharmaceutical Services, I)

Executive Summary

First-quarter 2018 reported net sales of $415.7 million grew 7.2% over the prior-year quarter. At constant currency, organic sales growth was 0.2%.
First-quarter 2018 reported-diluted EPS was $0.58. Excluding restructuring and other costs, first-quarter 2018 adjusted-diluted EPS was $0.62, as compared to $0.81 in the prior-year quarter. Tax benefits associated with share-based payment transactions were $0.03 in the first-quarter 2018, below our expectations of approximately $0.05 and below the $0.21 impact in the same quarter last year.
The Company is reaffirming full-year 2018 net sales guidance range of $1.720 billion to $1.730 billion. This assumes a translation exchange rate of $1.20 per Euro, unchanged from prior guidance. This represents a conservative assumption given current spot rates.
The Company continues to expect 2018 organic sales growth to be within a range of 6% to 8%.
The Company is reaffirming full-year 2018 adjusted-diluted EPS range of $2.80 to $2.90.
"Adjusted-diluted EPS," "net sales at constant currency" and "organic sales" are Non-GAAP measurements. See discussion under the heading "Non-GAAP Financial Measures" in this release.

Executive Commentary

"Our first-quarter 2018 results were in line with our expectations given the headwinds that we addressed in our last earnings release," said Eric M. Green, President and Chief Executive Officer. "We were pleased to see continued momentum in our Generics market unit and our Contract-Manufactured Products segment. After experiencing customer inventory management issues for much of 2017, our Generics team posted high-single digit organic sales growth, representing the third consecutive quarter of accelerating performance. Contract-Manufactured Products again saw strong growth led by diagnostic devices and injection devices associated with diabetes.

Mr. Green concluded, "We are reaffirming our full-year 2018 financial guidance. We anticipate accelerating organic sales growth over the remainder of the year, as the order flow in our Pharma market unit is expected to follow a similar pattern of improvement that we are experiencing in our Generics market unit. We continue to be the leader in the containment and delivery of injectable biologics and expect a return to normal long-term growth rates in the back half of the year. With sales growth returning to expected levels, gross and operating profit margins should improve as well. We remain on track for initial commercial sales from our Waterford facility later this year and are adding manufacturing capacity to address a growing demand for our administration systems."

First-Quarter 2018 Financial Results (comparisons to prior-year period)

First-quarter 2018 reported net sales of $415.7 million grew 7.2% over the prior-year quarter. At constant currency, organic sales growth was 0.2%. The deconsolidation of operations in Venezuela and the loss of a consumer-product contract manufacturing customer negatively impacted organic sales growth by 390 basis points.

Proprietary Products segment organic sales declined by 1.8%. The impact from the Venezuela deconsolidation negatively affected organic sales growth by 310 basis points. By market unit, first-quarter 2018 Proprietary Products segment sales growth was led by high-single digit growth in Generics, offset by a low-single digit decline in Biologics and a high-single digit decline in Pharma. The Pharma market unit experienced strong growth in the first-quarter last year, which made for an unfavorable growth comparison in Q1 2018. Contract-Manufactured Products segment organic sales growth was 7.9%, despite the loss of a consumer-product contract manufacturing customer.

First-quarter 2018 gross profit margin was 32.3%, compared to 34.6% in the same period last year, a decline of 230 basis points. Two main drivers of this decline were the deconsolidation of Venezuelan operations and the loss of a consumer-product contract manufacturing customer, which cumulatively accounted for $10.7 million of gross profit in the first quarter of last year and adversely affected gross profit margin by 150 basis points. Additionally, under-absorbed overhead from our Waterford facility more than offset gross profit margin improvement from higher efficiencies and price increases.

Effective January 1, 2018, the Company adopted the new accounting rules, which require an acceleration of the timing of revenue recognition on the sale of certain products and tooling agreements in both segments of our business. The cumulative effect had an immaterial negative impact to first-quarter 2018 net sales of $3 million. For the full-year 2018, the Company expects a reduction of $6 million to expected net sales.

The Company has also adopted the new rules for pension accounting. Instead of recognizing pension gains or losses in the "Selling, general and administrative expenses" line on the income statement, these gains or losses are now located "below the line" in non-operating income. The Company has restated Q1 2017 and full-year 2017 results to allow year-over-year comparisons with 2018 performance. The impact on the first-quarter 2018 from this pension accounting change was the reclassification of $1.6 million to Other Non-Operating Income. For the full-year 2018, we estimate that the total reclassification will be approximately $7 million.

In February 2018, the Company announced a restructuring program, expected to be implemented over the following twelve to twenty-four months, that will help streamline our manufacturing plant network and enable us to make investments to drive our high-value proprietary products and healthcare-related contract manufacturing business, and drive margin expansion. The plan will require restructuring expense in the range of $8.0 million to $13.0 million and capital expenditures in the range of $9.0 million to $14.0 million. Once fully completed, we expect that the plan will provide the Company with annualized savings in the range of $17.0 million to $22.0 million. During the three months ended March 31, 2018, the Company recorded $3.3 million in restructuring and related charges.

First-quarter 2018 operating profit margin was 12.8%. On an adjusted basis (excluding restructuring and related charges), operating profit margin was 13.6%, compared to 15.6% in the same period last year. The decline was primarily caused by lower gross profit margin.

For the first-quarter 2018, income tax expense was $12.5 million. Excluding restructuring costs and a net tax charge related to U.S. tax reform, the adjusted effective tax rate was 22.5%, compared to 3.6% in the same period last year. Tax benefits from stock-based compensation were $2.1 million in the first-quarter 2018 as compared to $15.9 million in the same period last year. Excluding benefits from stock-based payments, the effective tax rate was 26.3% as compared to 30.2% last year, which reflects the lower U.S. tax rate enacted at the end of 2017.

During the first-quarter 2018, the Company repurchased 540,000 shares of common stock at a cost of $47.9 million under its buyback program. There are up to 260,000 additional shares available to be repurchased under the program authorized by our Board of Directors that expires in December 2018.

Full-Year 2018 Financial Guidance

The Company continues to expect 2018 organic sales growth to be within our long-term projected 6-8% range. Excluding sales that will not recur in 2018 ($32.6 million of 2017 sales will not recur in 2018 due to the loss of a consumer-product contract manufacturing customer and deconsolidation of our Venezuelan operations), the Company expects 2018 organic sales growth to be at the higher end of that range.

The Company is reaffirming full-year 2018 net sales guidance range of $1.720 billion to $1.730 billion. This assumes a translation exchange rate of $1.20 per Euro. Given recent volatility in currency exchange rates, the Company believes it is prudent to use a conservative exchange. Full-year 2018 adjusted-diluted EPS is expected to be in a range of $2.80 to $2.90.

The Company estimates its 2018 capital spending will be less than $150 million.

First-Quarter Conference Call

The Company will host a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time today. To participate on the call please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 9889627.

A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the website three hours after the live call and will be available through Thursday, May 3, 2018, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 9889627.

Forward-Looking Statements

Certain forward-looking statements are included in this release. They use such words as "expected," "continue," "increase," "will," "estimated," "believe," "expect," "estimate," "see," "continued," "anticipate," "remain," and other similar terminology. These statements reflect management’s current expectations regarding future events and operating performance and speak only as of the date of this release. There is no certainty that actual results will be achieved in-line with current expectations. These forward-looking statements involve a number of risks and uncertainties. The following are some of the factors that could cause our actual results to differ materially from those expressed in or underlying our forward-looking statements: customers’ changing inventory requirements and manufacturing plans; customer decisions to move forward with our new products and product categories; average profitability, or mix, of the products we sell; dependence on third-party suppliers and partners; interruptions or weaknesses in our supply chain; increased raw material costs; fluctuations in currency exchange; and the ability to meet development milestones with key customers. This list of important factors is not all inclusive. For a description of certain additional factors that could cause the Company’s future results to differ from those expressed in any such forward-looking statements, see Item 1A, entitled "Risk Factors," in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017.

Except as required by law or regulation, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events, or otherwise.

Non-GAAP Financial Measures

This press release and the preceding discussion of the Company’s results, financial guidance, and the accompanying financial tables use the following financial measures that have not been calculated in accordance with U.S. generally accepted accounting principles (GAAP), and therefore are referred to as Non-GAAP financial measures:

Net sales at constant currency (organic sales growth)
Adjusted operating profit
Adjusted operating profit margin
Adjusted income tax expense
Adjusted net income
Adjusted diluted EPS
Net debt
Total invested capital
Net debt-to-total invested capital
The Company believes that these Non-GAAP measures of financial results provide useful information to management and investors regarding business trends, results of operations, and the Company’s overall performance and financial position. The Company’s executive management team uses these financial measures to evaluate the performance of the Company in terms of profitability and efficiency, to compare operating results to prior periods, to evaluate changes in the operating results of each segment, and to measure and allocate financial resources to its segments. The Company believes that the use of these Non-GAAP financial measures provides an additional tool for investors to use in evaluating ongoing operating results and trends in comparing its financial measures with other companies.

The Company’s executive management does not consider such Non-GAAP measures in isolation or as an alternative to such measures determined in accordance with GAAP. The principal limitation of these financial measures is that they exclude significant expenses and income that are required by GAAP to be recorded. In addition, they are subject to inherent limitations as they reflect the exercise of judgment by management about which items are excluded. In order to compensate for these limitations, Non-GAAP financial measures are presented in connection with GAAP results. The Company urges investors and potential investors to review the reconciliations of its Non-GAAP financial measures to the comparable GAAP financial measures, and not to rely on any single financial measure to evaluate the Company’s business.

Net sales at constant currency translates the current-period reported sales of subsidiaries whose functional currency is other than the U.S. dollar at the applicable foreign exchange rates in effect during the comparable prior-year period. In calculating adjusted operating profit, adjusted operating profit margin, adjusted income tax expense, adjusted net income and adjusted diluted EPS, the Company excludes the impact of items that are not considered representative of ongoing operations. Such items may include restructuring and related costs, certain asset impairments, other specifically-identified gains or losses, and discrete income tax items. A reconciliation of these adjusted Non-GAAP measures to the comparable GAAP financial measures is included in the accompanying tables.

The following is a description of the item excluded from adjusted operating profit, adjusted income tax expense, adjusted net income, and adjusted diluted EPS for the three months presented in the accompanying tables:

Restructuring and related charges – During the three months ended March 31, 2018, the Company recorded $3.3 million in restructuring and related charges, consisting of $2.0 million for severance charges, $0.1 million for non-cash asset write-downs, and $1.2 million for other non-cash charges.

Tax law changes – During the three months ended March 31, 2018, following additional analysis, the Company recorded a net tax charge of $0.3 million for the estimated impact of U.S. tax reform. During the three and twelve months ended December 31, 2017, the Company had recorded a provisional charge for the estimated impact of U.S. tax reform, based upon its then-current understanding of the U.S. tax reform and the guidance available at the time. The Company will continue to actively monitor the developments relating to U.S. tax reform, and will adjust its estimate as necessary during the one-year measurement period.

Transgene: €35.6 Million in Cash and Cash Equivalents as of March 31, 2018

On April 26, 2018 Transgene (Paris:TNG) (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies against cancers and infectious diseases, reported its business update for the quarter ending March 31, 2018 (Press release, Transgene, APR 26, 2018, View Source [SID1234525754]).

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During the first quarter of 2018, revenue from collaborative and licensing agreements was mainly composed of research services and royalties.

As of March 31, 2018, government financing for research expenditures mainly consisted of 25% of the research tax credit expected for 2018 (€1.6 million in the first quarter of 2018, comparable with the same period in 2017).

Cash, cash equivalents, available-for-sale financial assets and other financial assets:

Cash, cash equivalents, available-for-sale financial assets and other financial assets stood at €35.6 million as of March 31, 2018, compared to €41.4 million as of December 31, 2017. In the first quarter of 2018, Transgene’s cash burn was €5.8 million, compared to €5.5 million for the same period in 2017.

Key achievements:

TG4010:
First patient treated in Phase 2 trial combining TG4010, nivolumab (ICI) and chemotherapy in 1st line treatment of advanced non-small cell lung cancer patients. The trial being conducted in a clinical collaboration with Bristol-Myers Squibb (press release distributed on January 16, 2018).
TG1050/T101:
First patient treated in China in Phase 1 trial of T101 (based on TG1050 technology) in chronic hepatitis B. This trial is conducted through a joint-venture (50/50) based in China between Transgene and Tasly Pharmaceuticals Group (press release distributed on January 17, 2018).
Research:
Presentation of a poster with promising preclinical data on a novel viral vector (pseudocowpox, PCPV) at the AACR (Free AACR Whitepaper) (American Association for Cancer Research) Annual Meeting 2018, Chicago, IL, USA, April 14 – 18 (press release distributed on April 18, 2018).
Outlook:

Transgene expects its cash burn for 2018 to be comparable to 2017, based on its current development plan.

Transgene confirms that it expects readouts in 2018 for each of its 5 products in clinical development.

– End –

Notes to editors:
Transgene (Euronext: TNG), part of Institut Mérieux, is a publicly traded French biotechnology company focused on designing and developing targeted immunotherapies for the treatment of cancer and infectious diseases. Transgene’s programs utilize viral vector technology with the goal of indirectly or directly killing infected or cancerous cells. The Company’s lead clinical-stage programs are: TG4010, a therapeutic vaccine against non-small cell lung cancer, Pexa-Vec, an oncolytic virus against liver cancer, and TG4001, a therapeutic vaccine against HPV-positive head and neck cancers. The Company has several other programs in clinical development, including TG1050 (chronic hepatitis B) and TG6002 (solid tumors).
With its proprietary Invir.IOTM, Transgene builds on its world-leading expertise in viral vector engineering to design and generate a new generation of multifunctional oncolytic viruses.
Transgene is based in Strasbourg, France, and has additional operations in Lyon, as well as a joint venture in China.
Additional information about Transgene is available at www.transgene.fr.
Follow us on Twitter: @TransgeneSA

Disclaimer:
This press release contains forward-looking statements, which are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those anticipated. There can be no guarantee that (i) the results of pre-clinical work and prior clinical trials will be predictive of the results of the clinical trials currently underway, (ii) regulatory authorities will agree with the Company’s further development plans for its therapies, or (iii) the Company will find development and commercialization partners for its therapies in a timely manner and on satisfactory terms and conditions, if at all. The occurrence of any of these risks could have a significant negative outcome for the Company’s activities, perspectives, financial situation, results and development.
For a discussion of risks and uncertainties which could cause the Company’s actual results, financial condition, performance or achievements to differ from those contained in the forward-looking statements, please refer to the Risk Factors ("Facteurs de Risques") section of the Document de Référence, available on the AMF website (View Source) or on Transgene’s website (www.transgene.fr). Forward-looking statements speak only as of the date on which they are made, and Transgene undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future

Stemline Therapeutics Announces Clinical Presentations of SL-801 and SL-701 at the Upcoming ASCO Annual Meeting

On April 26, 2018 Stemline Therapeutics, Inc. (Nasdaq:STML), a clinical-stage biopharmaceutical company developing novel oncology therapeutics, reported that clinical data from SL-801 and SL-701 trials have been selected for poster presentations at the upcoming 54th Annual Meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), to be held from June 1-5, 2018, at McCormick Place in Chicago, Illinois (Press release, Stemline Therapeutics, APR 26, 2018, View Source [SID1234525753]). Details of the data presentations are outlined below.

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Title: Phase 2 trial of SL-701 in relapsed/refractory glioblastoma (GBM): Correlation of immune response with longer-term survival

Abstract number: 2058
Session: Central Nervous System Tumors
Presenter: David Peereboom, MD; Cleveland Clinic
Date: Saturday, June 2, 2018
Time: 1:15 – 4:45 PM CT
Title: Interim results from a Phase 1 trial of SL-801, a novel XPO-1 inhibitor, in patients with advanced solid tumors.

Abstract number: 2560
Session: Developmental Therapeutics—Clinical Pharmacology and Experimental Therapeutics
Presenter: Judy Wang, MD; Florida Cancer Specialists and Research Institute
Date: Monday, June 4, 2018
Time: 8:00 – 11:30 AM CT
Abstracts are scheduled to be released publicly on May 16, 2018 at 5 PM ET through the ASCO (Free ASCO Whitepaper) meeting website (www.asco.org). Following each presentation at the conference, the data presented will be available on Stemline’s website (www.stemline.com) under the Scientific Presentations tab.

About BPDCN
Please visit the BPDCN disease awareness booth (#4125) at ASCO (Free ASCO Whitepaper) 2018 and www.bpdcninfo.com.