On October 24, 2019 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the third quarter ending September 30, 2019 (Press release, Integra LifeSciences, OCT 24, 2019, View Source [SID1234542480]).

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Third Quarter 2019 Highlights

Reported revenues were $379.1 million, an increase of 3.6% over the third quarter of 2018, and organic revenues increased 4.7% over the prior year;

Foreign currency exchange rates negatively impacted reported revenues by $2.4 million in the third quarter of 2019;

Adjusted EBITDA margin was 24.2%, an increase of 120 basis points over the third quarter of 2018;

GAAP loss per diluted share was $(0.32), compared to GAAP earnings of $0.15 in the prior year. The GAAP loss was primarily due to a $59.9 million in-process research and development charge related to the acquisition of Rebound Therapeutics Corporation ("Rebound") in the third quarter of 2019. Adjusted earnings per diluted share were $0.68, an increase of 15.3% over the third quarter of 2018;

The Company is tightening its full-year reported revenue guidance to a range of $1.517 billion to $1.522 billion from its prior range of $1.515 billion to $1.525 billion. The Company is reaffirming full-year organic revenue growth of approximately 5%;

The Company is revising its GAAP earnings per diluted share guidance for the full year 2019 to a new range of $0.61 to $0.66 from the prior range of $1.46 to $1.53, a reduction primarily related to Rebound acquisition expenses. The Company is reaffirming guidance for adjusted earnings per diluted share in the range of $2.70 to $2.75.

"We are pleased to have exceeded our third quarter revenue and earnings guidance. For the second quarter in a row, our global CSS segment delivered broad-based strength and drove the outperformance," said Peter Arduini, Integra’s president and chief executive officer. "We have completed all the substantial Codman transition services activities and are reaffirming our full-year 2019 guidance for organic revenue growth and adjusted EPS."
Adjusted EBITDA for the third quarter of 2019 was $91.6 million, or 24.2% of revenue, compared to $84.3 million, or 23.0%, in the third quarter of 2018. The 120-basis point margin improvement was driven by higher revenue and improved operating leverage.
Adjusted net income for the third quarter of 2019 was $58.7 million, an increase of 16.0% from the prior year. The increase in adjusted net income is a result of higher revenues, improved operating leverage and lower interest expense. Adjusted earnings per diluted share for the third quarter of 2019 were $0.68, an increase of 15.3% over the prior year.
The Company reported a GAAP net loss of $(27.6) million, or $(0.32) per diluted share, in the third quarter of 2019, compared to GAAP net income of $13.3 million, or $0.15 per diluted share, in the third quarter of 2018, a decrease mostly attributable to expenses associated with the Rebound acquisition.
2019 Full-Year Outlook
The Company is tightening its full-year reported revenue guidance to a range of $1.517 billion to $1.522 billion from its prior range of $1.515 billion to $1.525 billion. The Company is reaffirming its full-year organic revenue growth guidance of approximately 5%.
The Company is revising its GAAP earnings per diluted share guidance for the full-year 2019 to a new range of $0.61 to $0.66 from the prior range of $1.46 to $1.53 due to higher acquisition and integration-related charges, primarily a $59.9 million in-process research and development expense related to Rebound. The Company is reaffirming guidance for adjusted earnings per diluted share in the range of $2.70 to $2.75.

In the future, the company may record, or expects to record, certain additional revenues, gains, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 AM ET today, Thursday, October 24, 2019, to discuss financial results for the third quarter and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.
Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.
Access to the live call is available by dialing (800) 367-2403 and using the passcode 7136796. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available through October 29, 2019 by dialing (888) 203-1112 and using the passcode 7136796. The webcast will also be archived on the website.

On October 24, 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, reported that it will participate in the Wolfe Research Inaugural Healthcare Conference on Wednesday, November 6 (Press release, AbbVie, OCT 24, 2019, View Source [SID1234542479]). Richard A. Gonzalez, chairman and chief executive officer, will present at 8:30 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

On October 24, 2019 West Pharmaceutical Services, Inc. (NYSE: WST) reported its financial results for the third-quarter 2019 and updated full-year 2019 financial guidance (Press release, West Pharmaceutical Services, OCT 24, 2019, View Source [SID1234542478]).

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Third-Quarter 2019 Summary (comparisons to prior-year period)

Net sales of $456.1 million grew 5.7%; organic sales growth was 7.9%; sales from a recent acquisition contributed an additional 20 basis points of growth; currency translation reduced sales by 240 basis points.
Reported-diluted EPS of $0.75 increased 3%.
Adjusted-diluted EPS of $0.79 increased 4%.
Company is raising its full-year 2019 net sales guidance to a new range of between $1.815 billion and $1.825 billion.
Company is raising full-year 2019 adjusted-diluted EPS guidance to a new range of between $3.10 and $3.15.
"Adjusted-diluted EPS" and "organic sales growth" are Non-U.S. GAAP measurements. See discussion under the heading "Non-U.S. GAAP Financial Measures" in this release.

"Our third-quarter results demonstrate the forward momentum we have seen throughout 2019. In line with our expectations, we are seeing strong customer uptake of our high-value products (HVPs), especially in the Biologics market unit," said Eric M. Green, President and Chief Executive Officer. "With the anticipated growing demand for our HVPs and positive trends in the marketplace, we expect our performance to continue to be strong for the remainder of the year and are raising our outlook for the full-year 2019."

Mr. Green continued, "Earlier this month, we announced an increase in our minority equity stake to 49 percent in Daikyo Seiko, Ltd. The expansion of our long-standing relationship, on an exclusive basis, will ensure our continued success and strengthen our partnership with Daikyo."

Proprietary Products Segment

Net sales grew by 6.2% to $345.2 million. Organic sales growth was 8.5%, with incremental sales from a recent acquisition contributing 30 basis points of Proprietary Products growth and currency translation decreasing sales by 260 basis points. HVPs (components and devices) represented 63% of segment sales and generated double-digit organic sales growth.

Our Biologics market unit had strong double-digit organic sales growth, led by customer purchases of NovaPure, Daikyo and Flurotec components as well as products incorporating Daikyo’s Crystal Zenith technology. Our Generics market unit posted mid-single digit organic sales growth, led by sales of Daikyo components, products incorporating Crystal Zenith technology, self-injection platforms and Westar RU. Our Pharma market unit saw a mid-single digit organic decline due to the impact of a previously reported voluntary recall of our Vial2Bag product.

Contract-Manufactured Products Segment

Net sales grew by 4.2% to $111.1 million. Organic sales growth was 6.0% with currency translation decreasing sales by 180 basis points. Segment performance was led by sales of healthcare-related injection and diagnostic devices.

Financial Highlights (first nine months of 2019)

Operating cash flow was $260.8 million, an increase of 21%. Capital expenditures were $88.8 million, compared to $74.7 million over the same period last year. Free cash flow (operating cash flow minus capital expenditures) was $172.0 million, an increase of 22%.

The Company recorded $3.8 million of restructuring and related charges through the first nine months of 2019 from actions we have taken that are intended to streamline our manufacturing network. This restructuring plan is expected to be completed by the end of 2019 and result in $7.0 million of restructuring and related charges in 2019. Implemented in first-quarter 2018, the Company expects cumulative expenses over the plan period to be approximately $16.0 million. Once fully completed, the Company anticipates that the plan will provide annualized savings of approximately $14.0 million.

Full-Year 2019 Financial Guidance

The Company is raising its full-year 2019 net sales guidance to a new range of between $1.815 billion and $1.825 billion, compared to the prior guidance range of between $1.810 billion and $1.825 billion.
Organic sales growth is expected to be approximately 8%.
Net sales guidance includes a headwind of $54 million for the full-year 2019 based on current foreign exchange rates, compared to prior guidance of a full-year negative impact of $42 million.
The Company is raising full-year adjusted-diluted EPS guidance to a new range of between $3.10 and $3.15, compared to the prior guidance range of between $3.00 and $3.10.
This includes an estimated headwind of approximately $0.13 based on current foreign currency exchange rates, compared to prior guidance of a headwind of $0.10.
The acquisition of an incremental minority stake in Daikyo Seiko, Ltd., is not expected to have a material impact to West’s full-year 2019 financial outlook.
Third-Quarter 2019 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 9278868.

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, October 31, 2019, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International) and entering conference ID 9278868.

On October 24, 2019 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the discovery, development and commercialization of immunotherapy products, reported the following updates to its clinical programs (Press release, Advaxis, OCT 24, 2019, View Source [SID1234542477]).

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ADXS-HOT: Cancer Type-Focused Hotspot/Off-the-Shelf Neoantigen-Directed Therapies – The ADXS-HOT program is a cancer-type specific immunotherapy that targets hotspot mutations, cancer testis antigens and oncofetal antigens. The first drug candidate from this program, ADXS-503, is designed to target most types of non-small cell lung cancer (NSCLC) and is currently being evaluated in a Phase 1/2 clinical trial, enrolling patients at five sites. The first dose level with monotherapy in Part A, (1 X108 CFU) has been completed and the Part A-second dose level (5 X108 CFU) and Part B in combination with a checkpoint inhibitor are currently open to enrollment. The Company plans to report immune response data from Part A monotherapy by the end of 2019.

Advaxis intends to file an investigational new drug (IND) application for its ADXS-504 (HOT Prostate) program by the end of 2019 and has completed manufacturing of its ADXS-506 (HOT Bladder) construct, enabling the construct to enter clinical development in the future.

ADXS-NEO: Personalized, Neoantigen-Directed Therapy – ADXS-NEO is a personalized neoantigen-directed immunotherapy designed to activate a patient’s immune system in a range of cancers. The company has enrolled its last patient in Part A, the monotherapy portion of its Phase 1 dose-escalation study, which was planned to be followed by Part B, dose escalation in combination with a checkpoint inhibitor. Data previously released on the ADXS-NEO program demonstrated the tolerability, to date, of this construct at 1 X108 CFU and indicated signals of a robust anti-tumor immune response. Additionally, the signals of anti-tumor immune responses included a strong CD8+ T cell reactivity generated against personalized as well as hotspot mutations, which provided valuable insight for the company’s HOT constructs. As the company moves into the combination arm of its HOT NSCLC study, it has determined that the information gained from the HOT NSCLC study will provide an opportunity to demonstrate the effects of its neoantigen constructs used in combination with a checkpoint inhibitor, thereby minimizing the benefits of entering Part B of the ADXS-NEO study. Therefore, the company has elected to not continue into Part B of the ADXS-NEO study in combination with a checkpoint inhibitor. The company plans to continue to dose the last patient enrolled in Part A in accordance with the protocol and cease further enrollment. The company intends to publish the final results from Part A of the ADXS-NEO study at a future medical meeting and close its ADXS-NEO program IND thereafter.

ADXS-PSA: Prostate Cancer – The company recently reported updated data for its Phase 1/2 KEYNOTE-046 study of ADXS-PSA, alone and in combination with KEYTRUDA (pembrolizumab), Merck’s anti-PD-1 therapy, for unselected and advanced patients with metastatic castration-resistant prostate cancer ("mCRPC").

The median overall survival for this patient population in the combination arm was 33.6 months (95% CI, range 15.4-33.6 months). These results are encouraging as the patient population in the combination arm (n=37) had high Gleason scores (9), MSI-high negative status, visceral metastatsis in 30%, prior chemotherapy in 57% and one to two prior next generation hormonal agents in >80% of patients. The company is in discussions with potential partners regarding opportunities to expand or advance this mCRPC program.

ADXS-HPV: A xalimogene filolisbac (AXAL):

– Cervical Cancer – As announced in July, the company is in the process of winding down its Phase 3 AIM2CERV study evaluating AXAL for the treatment of patients with high-risk, locally advanced cervical cancer. As a result of the closure of this study, the company will be unblinding the data and anticipates reporting the results of the 110 patients that had been dosed with AXAL in this study by the end of 2019.

– Lung Cancer –Global BioPharma, Inc. (GBP), the company’s partner in certain Asian and African territories, anticipates initiating its Phase 2, open-label controlled trial in HPV-associated NSCLC in patients following first-line chemotherapy by the end of 2019. The study will be assessing the effects of AXAL when combined with pemetrexed in patients with HPV+ NSCLC, following first line induction therapy.

"At Advaxis, we are committed to unlocking the potential benefits of our Lm TechnologyTM platform to improve outcomes for cancer patients," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "The NEO trial has provided us with valuable proof-of-mechanism data for our HOT program, with clinical signals of generation of CD8+ T cells against hotspot mutations, antigen spreading and stable disease in two patients. While discontinuing the NEO program was a difficult decision, we ultimately believe that the off-the-shelf approach of our HOT program will allow us to more effectively evaluate our platform in a broad patient population with a more economical, commercial-ready manufacturing process while also extending our cash runway until early 2021. I want to personally thank the patients, employees and collaborating physicians who participated in or assisted with this study." He concluded, "The strength of our technology and pipeline leave us well positioned to explore a variety of strategic opportunities heading into 2020."

On October 24, 2019 Heat Biologics, Inc. (NASDAQ:HTBX), a biopharmaceutical company developing immunotherapies designed to activate a patient’s immune system against cancer, reported that data from its ongoing Phase 2 trial of HS-110 was accepted for poster presentation at The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting (Press release, Heat Biologics, OCT 24, 2019, View Source [SID1234542476]). This data set represents a cohort of patients who have previously received a checkpoint inhibitor for advanced NSCLC, and whose disease has subsequently progressed. The study explores the efficacy of re-challenging the immune system with nivolumab in combination with HS-110 (a T-cell activating therapy) after checkpoint inhibitor failure.

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The poster, titled "Treating advanced non-small lung cancer (NSCLC) patients after checkpoint inhibitor treatment failure with a novel combination of Viagenpumatucel-L (HS-110) plus nivolumab," will be presented starting at 7AM Eastern Time on November 8, 2019.

The SITC (Free SITC Whitepaper) Annual Meeting is being held at the Gaylord National Hotel & Convention Center in National Harbor, Maryland on November 6-10, 2019.

About SITC (Free SITC Whitepaper) 2019

The Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 34th Annual Meeting provides a multidisciplinary educational and interactive environment focused on improving outcomes for current and future patients with cancer by incorporating strategies based on basic and applied cancer immunotherapy.

The Annual Meeting consists of cutting-edge research presentations by experts in the field, both oral and poster presentations, and ample opportunity for structured and informal discussions, including important networking opportunities. In addition, the meeting includes updates on major national and international initiatives coming from academia, government and industry, as well as important society projects.

Following SITC (Free SITC Whitepaper)’s tradition of collaborating to advance the field, SITC (Free SITC Whitepaper) 2019 features sessions collaboratively-developed with reputable organizations whose missions complement and align with that of SITC (Free SITC Whitepaper)’s. The meeting will conclude with the Hot Topic Symposium, an in-depth look at an emerging topic in the field.