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Monday, March 11, 2019

Organogenesis up ahead of Q4 report

Thinly traded small cap Organogenesis Holdings (ORGO +35.1%) is up on an 11x surge in volume, albeit on turnover of only 472K shares, on no apparent news.
On Monday, March 18, it is scheduled to release Q4 and 2018 results. On February 12, it reported that it expects Q4 revenues of $62.1M – 63.1M and 2018 revenues of $192M – 193M. 2018 assumptions include net revenue from Advanced Wound Care of $163.1M – 164M (down 8 – 9% yoy), $28.9M – 29M (up 47 – 48%) in net revenue from Surgical & Sports Medicine and $68.1M – 69.1M from PuraPly (down 37 – 38%).
2019 guidanceRevenues: $248M – 259M (up 29 – 35%); Advanced Wound Care: 219M – 229M (up 34 – 40%); Surgical & Sports Medicine: $29.5M – 31M (up 2 – 7%); PuraPly: $96M – 103M (up 40 – 50%).
Next Wednesday, March 20, management will deliver a corporate overviewat Oppenheimer’s Annual Healthcare Conference in New York City.
Last month, the company filed a prospectus for the resale of up to ~31.4M shares of common stock by current investors.

Lilly: Elanco Exchange Offer Oversubscribed

Eli Lilly and Company (NYSE: LLY) today announced that, based on preliminary results, its previously-announced offer for shareholders to exchange their shares of Lilly common stock for shares of Elanco Animal Health Incorporated (NYSE: ELAN) owned by Lilly was oversubscribed. The exchange offer expired at 12:00 midnight, New York City time, at the end of the day on March 8, 2019. Under the terms of the exchange offer, 4.5121 shares of Elanco common stock will be exchanged for each share of Lilly common stock accepted in the exchange offer.
According to the exchange agent, Computershare Trust Company, N.A., 492,109,007 shares of Lilly common stock were validly tendered and not validly withdrawn, including 179,675,890 shares that were tendered by notice of guaranteed delivery. Today, Lilly intends to accept 65,000,775 of the tendered shares in exchange for the 293.29 million shares of Elanco common stock owned by Lilly. Because the exchange offer was oversubscribed, Lilly is accepting only a portion of the shares of its common stock that were validly tendered and not validly withdrawn, on a pro rata basis in proportion to the number of shares tendered. Shareholders who owned fewer than 100 shares of Lilly common stock, or an “odd-lot,” who have validly tendered all of their shares, will not be subject to proration, in accordance with the terms of the exchange offer.
Based on the total number of shares of Lilly common stock reported to be tendered prior to the expiration of the exchange offer, it is estimated that approximately 13.2 percent of the tendered shares of Lilly common stock will be exchanged, assuming all shares tendered by guaranteed delivery procedures are delivered under the terms of the exchange offer. This preliminary proration factor is subject to change based on the number of tendered shares that satisfy the guaranteed delivery procedures, as well as the number of “odd-lot” shares that were validly tendered and are not subject to proration. Lilly expects to announce the final proration factor on March 13, 2019, promptly following the expiration of the guaranteed delivery period.
Shares of Lilly common stock tendered but not accepted for exchange will be returned to the tendering shareholders in book-entry form promptly. In addition, the exchange agent will promptly credit shares of Elanco common stock for distribution in the exchange offer in book-entry form to accounts maintained by the Elanco transfer agent for tendering shareholders who have validly tendered and not validly withdrawn their shares of Lilly common stock. Checks in lieu of fractional shares of Elanco common stock will be delivered after the exchange agent has aggregated all fractional shares and sold them in the open market.
Reflecting the exchange of 65.0 million shares of Lilly’s outstanding common stock, the company currently estimates full year 2019 weighted-average diluted shares outstanding to be approximately 938 million for GAAP earnings per share and 924 million for non-GAAP earnings per share. Because the exchange offer was effective on March 11, 2019, Lilly will recognize only a partial-year benefit for the reduction in its common stock for GAAP weighted-average diluted shares outstanding. For non-GAAP weighted-average diluted shares outstanding, however, the company will assume that the exchange offer occurred as of January 1, 2019. Management believes that reducing full-year 2019 non-GAAP weighted-average diluted shares outstanding by the 65.0 million shares exchanged can be useful as investors compare results across periods. Lilly will provide updated GAAP and non-GAAP financial guidance in its Q1 2019 earnings announcement scheduled for April 30, 2019.

Arrowhead begins dosing in Phase 1 study of ARO-APOC3

Arrowhead Pharmaceuticals announced that it has dosed the first subjects in a Phase 1 clinical study of ARO-APOC3, an RNAi-based investigational medicine targeting Apolipoprotein C-III being developed for the treatment of hypertriglyceridemia.

Celgene submits application to EMA for ozanimod for treament of MS

Celgene Corporation announced that the company has submitted a Marketing Authorization Application to the European Medicines Agency for ozanimod for the treatment of adults with relapsing-remitting multiple sclerosis. Ozanimod is an oral, sphingosine 1-phosphate receptor modulator, which binds with high affinity selectively to S1P subtypes 1 and 5. The pivotal efficacy and safety data provided in the application result from the SUNBEAM and RADIANCE Part B phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled trials. The company remains on track to submit a New Drug Application to the U.S. Food and Drug Administration for relapsing forms of MS by the end of March. Ozanimod is an investigational compound that is not approved for any use in any country.

Strongbridge Biopharma announces findings from Phase 3 SONICS study

Strongbridge Biopharma announced the top-line findings from the extended evaluation phase of the pivotal Phase 3 SONICS study of Recorlev for the potential treatment of endogenous Cushing’s syndrome. The purpose of the six-month extended evaluation phase was to evaluate the long-term safety, tolerability and benefit-risk during chronic use of Recorlev. Overall, 60 out of 61 study participants who completed the maintenance phase elected to participate in the extended evaluation phase. Of the 60 patients that entered the extended evaluation phase, 46 patients completed it Data were collected twice, at three-month intervals, which is common practice for the long-term follow-up of chronic medical therapy for endogenous Cushing’s syndrome. Four patients discontinued due to adverse events. No patients experienced an increase in either alanine aminotransferase or aspartate aminotransferase greater than three times the upper limit of normal and there were no reported adverse events of special interest related to liver injury or dysfunction. The most commonly reported treatment-emergent adverse events in the extended evaluation phase were arthralgia, QTc prolongation, headache, hypokalemia and nasopharyngitis. Nausea and headache were reported at lower rates as compared to the previously reported aggregate rates of 32% and 28% from the dose titration and maintenance phases. At the end of the extended evaluation phase, normalization of mUFC was observed in 41% of patients, and normalization of, or at least 50% improvement in, mUFC was observed in 68% of patients. Clinically meaningful improvements in key cardiovascular risk markers were observed throughout the extended evaluation phase. Weight loss and reduction in body mass index continued throughout the extended evaluation phase.

Principia Biopharma reacquires rights to oral immunoproteasome program

Principia Biopharma (PRNB) announced a mutual agreement with AbbVie (ABBV) to end their collaboration aimed at developing oral immunoproteasome inhibitors and for Principia to reacquire the rights to the program. The two companies have agreed to conclude the collaboration effective March.

Neurotrope says has 24-36 months of cash for continuing operations

As of December 31, 2018, the company had approximately $28.8M of cash and cash equivalents. The company raised approximately $20.5M of net cash proceeds in December 2018. With these funds and its cash on hand, the company estimates that it has between 24-36 months of cash for continuing operations. “Given our strong cash position, which was bolstered by our recent fundraising, we are very well positioned to continue with our ongoing confirmatory clinical trial and other development activities,” stated Dr. Charles Ryan, Neurotrope’s CEO. “With 24 to 36 months of cash available for research and development and operations, we do not anticipate needing to raise additional capital anytime in the near future.”