Perrigo Company plc Reports Fourth Quarter And Full-Year 2018 Financial Results

On February 27, 2019 Perrigo Company plc (NYSE; TASE: PRGO) reported financial results for the fourth quarter and calendar year ended December 31, 2018 (Press release, Perrigo Company, FEB 27, 2019, View Source [SID1234533845]).

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Perrigo President and CEO Murray S. Kessler commented, "While 2018 was a difficult year for Perrigo, significant progress was made in the fourth quarter against the Company’s transformation plans. Market share in our consumer businesses were stable for the year, and the Company met its updated full-year 2018 guidance expectations despite an unusual equipment start-up issue at one of our facilities that resulted in a fourth quarter adjusted EPS headwind of approximately $0.08. It was also encouraging to see a meaningful, sequential improvement in the RX segment during the fourth quarter, as downward pricing pressure eased."

Kessler continued, "While the Company is facing a number of challenges, I am pleased with the rapid progress our team is making on its transformation plans and evolution from a healthcare company to a consumer self-care company. We are continuing to make significant progress with the separation of the RX business and recently received the $250 million milestone payment related to Tysabri."

Kessler concluded, "We look forward to sharing our strategy as well as providing demonstrable progress at our Investor Day presentation on May 9, 2019 in New York City. Investors can expect to see the Company’s plans for portfolio reconfiguration, capacity and technology investments, innovation initiatives, cost savings plans to help fuel growth, capital allocation plans, organizational effectiveness initiatives and calendar 2019 guidance at that time. While there is much work to do, I remain excited and confident in our ability to recapture the ‘Perrigo Advantage’ and bring the Company back to profitable and sustainable growth."

Refer to Tables I – VI at the end of this press release for a reconciliation of non-GAAP measures to the current year and prior year periods and additional non-GAAP information. The Company’s reported results are included in the attached Condensed Consolidated Statements of Operations, Balance Sheets and Statements of Cash Flows.

Calendar year 2017 net sales have been adjusted to exclude approximately $21 million of sales attributable to the divested Israel API business.

Reported net sales for calendar year 2018 were approximately $4.7 billion, which included new product sales of $170 million, partially offset by discontinued products of $66 million. Adjusted net sales decreased 4.6% on a constant currency basis. Unfavorable currency movements impacted net sales by $34 million.

Reported net income was $131 million, or $0.95 per diluted share, versus $120 million, or $0.84 per diluted share, in the prior year. Excluding charges as outlined in Table I, calendar year 2018 adjusted net income was $629 million, or $4.55 per diluted share, versus $703 million, or $4.93 per diluted share, last year.

Fourth Quarter Results

Fourth quarter 2017 net sales have been adjusted to exclude approximately $4 million of sales attributable to the divested Israel API business.

Net sales for the fourth quarter of calendar year 2018 were approximately $1.2 billion, which included new product sales of $51 million, partially offset by discontinued products of $16 million. Adjusted net sales decreased 5.1% on a constant currency basis. Unfavorable currency movements impacted net sales by $18 million.

Reported net income was $82 million, or $0.60 per diluted share, versus $73 million, or $0.52 per diluted share, in the prior year. Excluding charges as outlined in Table I, fourth quarter 2018 adjusted net income was $132 million, or $0.97 per diluted share, versus $180 million, or $1.28 per diluted share, for the same period last year.

CHC Americas segment net sales were down 4.1% compared to last year. Net sales in the analgesics and smoking cessation categories coupled with new product sales of $10 million, were more than offset by lower net sales in the animal health and nutrition categories. Discontinued products in the quarter were $10 million, of which $6 million related to the animal health business. Excluding the animal health business, CHC Americas net sales decreased approximately 1.9% on a constant currency basis.

CHC Americas’ fourth quarter reported gross profit margin was 29.5%. Adjusted gross profit margin was 30.4% or 560 bps lower than the prior year. The majority of this decline was due to an unusual equipment startup issue at one facility, higher input costs and greater operating inefficiencies, including service-related challenges.

Reported fourth quarter operating margin was 16.4%. Fourth quarter adjusted operating margin was 18.0%, lower than the prior year due primarily to adjusted gross margin flow through, partially offset by lower administrative expenses.

CHC International net sales were relatively flat, excluding $2 million in net sales from exited businesses in 2017 and unfavorable foreign currency movements of $17 million. Net sales in the diagnostics and analgesics categories, in addition to new product sales of $19 million, were mostly offset by lower net sales in the lifestyle and cough cold categories. The absence of net sales from discontinued products was $2 million.

Reported and adjusted gross margin decreased 110 bps versus a year ago due primarily to less favorable product mix.

Reported operating margin was (0.5)%. Adjusted operating margin decreased 240 basis points to 12.9%. Growth investments in advertising and R&D increased approximately 350 bps as a percentage of net sales compared to prior year. These increases were partially offset by lower selling and administrative expenses.

RX net sales were $222 million in the quarter, lower than the prior year due primarily to industry dynamics, including pricing pressure, supply constraints in a few products and discontinued products of $4 million. New product sales were $22 million.

Reported gross margin was 45.5%. Adjusted gross margin was 54.8%, or 160 bps higher than the same quarter last year, driven primarily by new product launches.

Reported operating margin was 30.5%. Adjusted operating margin was 39.2%, or 110 bps higher than the prior year due primarily to adjusted gross margin flow through while maintaining R&D dollar investments for growth.

Conference Call

The Company will host a conference call at 4:30 p.m. EST (1:30 p.m. PST), February 27, 2019. The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 0121144. A taped replay of the call will be available beginning at approximately 8:00 p.m. (EST) Wednesday, February 27, 2019, until midnight March 6, 2019. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10128203.

Context Announces Presentation of New Antiprogestin at the 2019 AACR Annual Meeting

On February 27, 2019 Context Therapeutics, a clinical-stage biotechnology company, reported that new preclinical data on CTX-30916, a new PR antagonist, will be featured at the upcoming AACR (Free AACR Whitepaper) Annual Meeting taking place in Atlanta, Georgia (Press release, Context Therapeutics, FEB 27, 2019, View Source [SID1234533830]). The data will be presented during the Receptors and Growth Factors session on April 1, 2019 from 1:00 PM – 5:00 PM.

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At the conference Dr. Deepak Lala, Ph.D., Chief Technology Officer for Context Therapeutics and Dr. Tasir Haque Ph.D., Head of Chemistry for Context Therapeutics will present preclinical data highlighting the biochemical and cellular activity of CTX-30916 including its mechanism of action in inhibiting breast cancer cell proliferation. CTX-30916 is a next generation PR antagonist with potential for the treatment of breast, uterine, and ovarian cancers.

The poster details are as follows:

Poster Title: Identification of CTX-30916 as a new antagonist of progesterone receptor signaling pathways

Session Category: Molecular and Cellular Biology / Genetics

Session Title: Receptors and Growth Factors

Session Date and Time: Monday Apr 1, 2019 1:00 PM – 5:00 PM

Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 38

Poster Board Number: 4

Abstract Number: 2625

For more information on AACR (Free AACR Whitepaper) 2019, please visit View Source

PRESS RELEASE Bolt Biotherapeutics To Present Preclinical Proof of Concept Data at American Association for Cancer Research (AACR) Conference

On February 27, 2019 Bolt Biotherapeutics, Inc., a biotechnology company focused on unleashing the power of the immune system to achieve anti-tumor immunity in patients with its promising Immune-Stimulating Antibody Conjugate (ISAC) platform, reported the forthcoming presentation of preclinical data on its BoltbodyTM technology at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference (Press release, Bolt Biotherapeutics, FEB 27, 2019, View Source [SID1234533828]). The conference will be held March 29th through April 3rd in Atlanta, Georgia.

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Details relating to the presentation are as follows:
Abstract Title: TLR7/8 immune-stimulating antibody conjugates elicit robust myeloid activation leading to enhanced effector function and antitumor immunity in pre-clinical models.
Abstract Number: 1559
Date and Time: Monday, April 1, 2019, 8am – 12pm EDT
Session Category: Immunology Session Title: Therapeutic Antibodies
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 25, Poster Board 28

"We are pleased that the first public presentation of our BoltbodyTM technology will occur at the AACR (Free AACR Whitepaper) Annual Meeting," stated David Dornan, Ph.D., senior vice president of research at Bolt Biotherapeutics. "BoltbodyTM ISACs are a new class of therapeutics that harness the ability of toll-like receptor (TLR) agonists to convert cold tumors into immunologically hot tumors following systemic administration. We are rapidly advancing our lead BoltbodyTM therapeutic toward the clinic based upon the promising data."

"It is exciting to share the encouraging data generated by this unique technology which builds upon our growing understanding of the role of myeloid cells in generating effective anti-tumor immunity. Our poster will cover in vitro and in vivo data demonstrating that BoltbodyTM ISACs have the capacity to eliminate tumors in preclinical models," stated Ed Engleman, M.D., Bolt founder and co-director of the Immunology and Immunotherapy Research Program at the Stanford Cancer Institute.

About Bolt Biotherapeutics’ Immune-Stimulating Antibody Conjugate (ISAC) Platform Technology
The Boltbody platform consists of Immune-Stimulating Antibody Conjugates (ISAC) that harness the ability of TLR agonists to convert cold tumors into immunologically hot tumors (illuminating tumors to the immune system allowing them to be invaded by tumor killing cells). BoltbodyTM ISACs have demonstrated the ability to eliminate tumors following systemic administration in preclinical models and have also led to the development of immunologic memory.

CRISPR Therapeutics Announces Presentations at the American Association for Cancer Research 2019 Annual Meeting

On February 27, 2019 CRISPR Therapeutics (NASDAQ: CRSP), a biopharmaceutical company focused on creating transformative gene-based medicines for serious diseases, reported that members of the CRISPR team will present two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held March 29 to April 3, 2019, at the Georgia World Congress Center in Atlanta, GA (Press release, CRISPR Therapeutics, FEB 27, 2019, View Source [SID1234533813]).

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Title: Allogeneic CRISPR/Cas9 gene-edited CAR-T cells targeting CD33 show potent preclinical activity against AML cells (abstract #1428, poster)
Time and Date: Monday, April 1, 2019, from 8:00 a.m. to 12:00 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 21

Title: Targeting multiple solid tumor types with anti-CD70 allogeneic CAR-T cells (abstract #3184, poster)
Time and Date:Tuesday, April 2, 2019, from 8:00 a.m. to 12:00 p.m. ET
Location: Georgia World Congress Center, Exhibit Hall B, Poster Section 22

OPKO Health Reports 2018 Fourth Quarter Business Highlights and Financial Results

On February 27, 2019 OPKO Health, Inc. (NASDAQ: OPK) reported business highlights and financial results for the three months ended December 31, 2018 (Press release, Opko Health, FEB 27, 2019, View Source [SID1234533812]).

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Business Highlights

RAYALDEE total prescriptions reported by IQVIA increased 166% in 4Q 2018 compared with 4Q 2017: Total prescriptions were approximately 9,300 during the fourth quarter of 2018. As of January 1, 2019, approximately 80% of prospective U.S. patients have access to RAYALDEE under their insurance plans. The Company continues to increase its commercial reach through expansion of its sales force.
Topline data from the global Phase 3 clinical trial for hGH-CTP in growth hormone deficient children is expected by the end of 2019; Enrollment completed in Japanese registration study: The global pediatric study is a pivotal, non-inferiority design comparing a single weekly administration of hGH-CTP with daily injections of a currently marketed growth hormone product. The global and Japanese pediatric studies utilize the pen device and formulation that will be launched commercially upon approval. The pediatric segment represents more than 80% of the commercial market for treatment of hGH deficiency.
RAYALDEE line extension trial initiated in hemodialysis patients with SHPT: Together with its partners, Vifor Fresenius and Japan Tobacco, OPKO is developing RAYALDEE for patients with Stage 5 CKD who have secondary hyperparathyroidism (SHPT) and vitamin D insufficiency and are undergoing regular hemodialysis. A Phase 2 trial in this population is currently underway in the United States.
Topline data from the Phase 2b study with OPK88003, a once-weekly oxyntomodulin dual GLP1-Glucagon agonist for type 2 diabetes and obesity, is anticipated during 1Q 2019: The last patient, last visit of this Phase 2b dose-escalation study occurred in February 2019. In an earlier, 420-patient Phase 2 trial in patients with type 2 diabetes, OPK88003 was similar to exenatide extended-release (Ex ER) in reducing HbA1c levels. OPK88003 showed statistically significantly greater weight loss and lowering of total cholesterol and triglycerides compared to once-weekly Ex ER, with a good safety profile.
Appointed Jon R. Cohen, M.D. Executive Chairman and promoted Geoff Monk as President, both for BioReference Laboratories: Dr. Cohen brings more than 30 years of healthcare experience as a seasoned strategic leader with extensive and diverse experience; his track record of expanding existing business and developing new ventures, while dealing effectively with the payor universe, is well recognized in the diagnostics industry.
4Kscore utilization remained strong during 4Q 2018 with nearly 20,000 tests performed: The 4Kscore test is a blood test that gives a man with elevated prostate specific antigen (PSA) levels a personalized prediction of his chance of having or developing an aggressive form of prostate cancer. The Company is pursuing U.S. Food and Drug Administration (FDA) approval with a submission expected in the first half of 2019. OPKO announced on January 31, 2019 that Novitas Solutions, Inc. issued a notice of a future non-coverage determination for 4Kscore effective March 20, 2019. The Company is currently making efforts to have the determination rescinded or reversed.
FDA approved Claros point-of-care (POC) PSA test: On February 1, 2019, OPKO announced that the FDA approved the Company’s point-of-care Sangia Total PSA Test using the Claros 1 Analyzer. The Company is taking steps to obtain CLIA waiver for the test and analyzer, which would permit the test to be performed by most medical office personnel with minimal training, and is also planning for scale up of manufacturing capacity during 2019. OPKO plans to expand the testing menu and the next test under development is testosterone, with clinical trials currently scheduled to commence in mid-2019.
Financial Highlights

Net loss for the fourth quarter of 2018 of $76.1 million compared to $217.9 million for the comparable quarter of 2017. Net loss for both periods included unusual or non-cash items consisting of:

During the fourth quarter of 2018, the Company recorded $21.8 million of non-cash impairment to Goodwill and in-process research and development related to its active pharmaceutical ingredient business and the suspension of the Phase 2b clinical trial for its selective androgen receptor antagonist for benign prostatic hyperplasia. In the comparable period of 2017, the Company recorded a $13.2 million impairment resulting from the discontinuation by its licensee of the intravenous formulation of VARUBI;

During the fourth quarter of 2018, the Company incurred approximately $8.0 million of expenses related to defense and investigation of actions brought by the U.S. Securities and Exchange Commission (SEC) and related civil lawsuits. The Company reached a settlement agreement with the SEC in the fourth quarter of 2018, which was finalized in January 2019; and

During the fourth quarter of 2017, the Company recorded $73.3 million of adjustments to revenue from services.

Consolidated revenues for the fourth quarter of 2018 were $221.9 million compared with $161.0 million for the comparable period of 2017. During the 2018 quarter, revenue from services was $183.1 million, revenue from products was $25.4 million, including RAYALDEE revenue of $6.0 million, and revenue from licensing and intellectual property was $13.4 million.
During the fourth quarter of 2018, total operating expenses were $311.9 million, including the aforementioned impairment charges of $21.8 million as well as continued investment in the Company’s pharmaceutical pipeline, with R&D expense of $33.3 million.
The Company recorded a $28.3 million income tax benefit during the fourth quarter of 2018 primarily as a result of valuation allowance releases in foreign jurisdictions. The comparable period of 2017 includes a $61.2 million income tax provision, principally as a result of the Tax Cuts and Jobs Act ($31.8 million) as well as recording a valuation allowance against U.S. based deferred tax assets.
Subsequent to the close of the fourth quarter, on February 5, 2019, OPKO completed the sale of $200 million aggregate principal amount of 4.5% Convertible Senior Notes due 2025.
CONFERENCE CALL & WEBCAST INFORMATION

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time today. The conference call dial-in and webcast information is as follows:

DOMESTIC DIAL-IN: 866-634-2258
INTERNATIONAL DIAL-IN: 330-863-3454
PASSCODE: 4254518
WEBCAST: View Source

For those unable to participate in the live conference call or webcast, a replay will be available beginning approximately two hours after the close of the conference call. To access the replay, dial 855-859-2056 or 404-537-3406. The replay passcode is 4254518. The replay can be accessed for a period of time on OPKO’s website at View Source