surf1944
16年前
Tercica Reports Second Quarter 2008 Financial Results
Thursday July 31, 1:30 am ET
BRISBANE, Calif.--(BUSINESS WIRE)--Tercica, Inc. (Nasdaq: TRCA - News) today announced financial results for the quarter ended June 30, 2008. Net product sales totaled $6.2 million, compared to $2.0 million in the second quarter of 2007. Net product sales for Increlex® and Somatuline® Depot in the second quarter of 2008 were $4.6 million and $1.6 million, respectively.
Net loss for the second quarter of 2008 was $11.4 million, or $0.22 per share, compared to a net loss of $12.8 million, or $0.26 per share, for the second quarter of 2007.
Cash, cash equivalents and short-term investments as of June 30, 2008 were $71.4 million, compared to $94.9 million as of March 31, 2008.
Company Updates
Agreement and Plan of Merger with Ipsen.
On June 4, 2008, Tercica announced that Tercica and an affiliate of Ipsen, S.A. entered into an agreement and plan of merger by which an affiliate of Ipsen would acquire all of the shares of Tercica common stock that Ipsen does not currently own at a price of $9.00 per share in cash.
On July 24, 2008, Tercica announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and clearance by the German antitrust regulatory authority in connection with the agreement and plan of merger. Assuming satisfaction of the closing conditions in the agreement and plan of merger, including stockholder approval, Tercica estimates that the completion of the merger transaction should take effect late in the third quarter or early in the fourth quarter of 2008.
On July 24, 2008, Tercica also announced that Ipsen exercised in full the warrant issued by Tercica in October 2006, converted in full three convertible notes issued by Tercica in October 2006 and September 2007, and purchased 410,831 additional shares of the common stock of Tercica upon exercise of its pro rata rights to purchase shares in connection with other equity issuances by Tercica. Total cash proceeds from the warrant exercise and purchase of additional shares by Ipsen were $40.3 million.
http://biz.yahoo.com/bw/080731/20080730006479.html?.v=1
surf1944
17年前
Tercica Reports First Quarter 2008 Financial Results
Monday May 12, 4:05 pm ET
BRISBANE, Calif.--(BUSINESS WIRE)--Tercica, Inc. (Nasdaq:TRCA - News) today announced financial results for the quarter ended March 31, 2008. Total net product sales totaled $4.3 million, compared to $1.1 million in the first quarter of 2007. Net product sales for Increlex® and Somatuline® Depot in the first quarter 2008 were $3.4 million and $1.0 million, respectively.
Net loss for the quarter was $17.5 million, or $0.34 per share, compared to a net loss of $12.4 million, or $0.25 per share, for the first quarter of 2007.
Research and development expenses for the first quarter of 2008 were $6.1 million, compared to $4.9 million for the first quarter of 2007, due to increases in development activities associated with Tercica’s next-generation growth hormone product candidates. Selling, general and administrative expenses for the first quarter of 2008 were $12.4 million, compared to $9.6 million for the first quarter of 2007, due to increases in sales and marketing costs associated with the launch of Somatuline® Depot.
Cash, cash equivalents and short-term investments as of March 31, 2008 were $94.9 million, compared to $113.5 million as of December 31, 2007.
“The launch of Somatuline Depot is progressing well. Sales of Increlex in the first quarter reflected seasonality in the short stature market, reductions in inventory levels at certain key specialty pharmacies, as well as delays in commercial shipments to patients who have switched their insurers. With year to date revenues as of today totaling approximately $7.4 million, we remain on track to achieve our 2008 total revenue guidance of $30 to $37 million and year-end cash guidance of $40 million,” said John A. Scarlett, M.D., Tercica’s Chief Executive Officer. “Also regarding Increlex, initial efficacy and safety data from our IGFD Registry was well received when presented to participating investigators in February 2008. This is the first Increlex data pertaining to children who are representative of the patient population being treated by physicians today. We are pleased with the growth rates seen on Increlex therapy and with the positive safety data that were presented,” he added.
Product Updates:
http://biz.yahoo.com/bw/080512/20080512006317.html?.v=1
surf1944
17年前
Tercica Reports Third Quarter 2007 Financial Results
--Somatuline Depot Launched in the U.S. for the Treatment of Acromegaly--
--Increlex Has Now Been Prescribed for More Than 1,000 Patients--
Tercica, Inc. (Nasdaq:TRCA) today announced financial results for the quarter ended September 30, 2007. Net product sales totaled $2.9 million, compared with $316,000 in the third quarter of 2006. Total net revenues for the quarter totaled $23.4 million, including a licensing milestone of $20.3 million in connection with the marketing authorization of Increlex® 10 mg/ml solution for injection in the European Union pursuant to the Increlex® License Agreement with Ipsen. Net profit for the quarter was $3.4 million, or $0.07 per share, compared with a net loss of $13.1 million, or $0.35 per share, for the third quarter of 2006. Total costs and expenses were $19.1 million for the quarter ended September 30, 2007, compared with $14.2 million for the same period in 2006.
Tercica reported product sales of $6.0 million for the nine months ended September 30, 2007. Total net revenues for the nine months ended September 30, 2007, including the licensing milestone of $20.3 million, were $26.9 million. Net loss for the first nine months of 2007 was $21.8 million, or $0.43 per share, compared with $42.0 million, or $1.14 per share, for the first nine months of 2006. Total costs and expenses for the nine months ended September 30, 2007 were $50.4 million, compared with $45.1 million for the same period in 2006.
Cash, cash equivalents and short-term investments as of September 30, 2007 were $127.7 million, compared with $98.0 million as of June 30, 2007.
“Along with continued positive commercial momentum for Increlex, we achieved two major corporate milestones in the third quarter when Somatuline Depot was approved in the United States for the treatment of acromegaly and Increlex was granted marketing authorization in the European Union for severe Primary IGFD,” said John A. Scarlett, M.D., Tercica’s President and Chief Executive Officer. “With our launch of Somatuline Depot, Tercica has now become a well-balanced biotechnology company with two commercial products and an exciting pipeline that includes our next-generation growth hormone products targeting an existing billion dollar market opportunity,” added Dr. Scarlett.
Recent Highlights and Updates
Increlex®
* On August 3, 2007, the European Commission granted marketing authorization for Increlex®. The authorized indication is for the long-term treatment of growth failure in children and adolescents with severe primary insulin-like growth factor-1 deficiency.
* The European Medicines Agency (EMEA) has granted Increlex® orphan drug exclusivity for the treatment of severe Primary IGFD, providing a 10-year period of marketing exclusivity for the approved indication.
* Increlex® net product sales increased 39% to $2.9 million in the third quarter of 2007, compared with $2.0 million in the second quarter of 2007.
* A major commercial milestone was achieved when Increlex® was prescribed for the 1,000th patient with short stature.
* As of September 30, 2007, a cumulative total of over 600 patients had received reimbursement approval.
* As of September 30, 2007, 307 physicians, or more than 60% of the pediatric endocrinologists to whom we promote, had prescribed Increlex®.
Somatuline® Depot
* On August 30, 2007, Tercica received notice of approval from the U.S. Food and Drug Administration (FDA) for marketing Somatuline® Depot (lanreotide) Injection 60, 90 and 120 mg/ml in the United States for the treatment of acromegaly.
* The FDA has granted Somatuline® Depot orphan drug exclusivity for the treatment of acromegaly, providing a seven-year period of marketing exclusivity.
* In the third quarter, the company completed the planned expansion of its sales force to launch Somatuline® Depot which will soon be available for commercial use in the United States.
* Enrollment began in the SALSA study, which is an open-label clinical study of Somatuline® Depot designed to assess self or partner administration in American patients with acromegaly. A similar study was conducted previously in the United Kingdom.
Financial
* In connection with Tercica’s Increlex® license with Ipsen, the marketing authorization of Increlex® in the European Union triggered a €15 million (approximately $19.3 million, net of withholding taxes) milestone payment by Ipsen to Tercica. Pursuant to our Somatuline® Depot license with Ipsen, the FDA approval of Somatuline® Depot triggered issuance of two notes by Tercica to Ipsen. The first note is a €30 million note (convertible into Tercica common stock at a conversion price of €5.92). The second note is a $15 million note (convertible into Tercica common stock at $7.41). The €30 million note was issued to Ipsen in lieu of the milestone payment of €30 million from Tercica to Ipsen that was triggered by the FDA approval of Somatuline® Depot. The $15 million note was issued to Ipsen for cash.
* In connection with the Genentech Combination Product Development and Commercialization Agreement entered into in July 2007 and a stock purchase by Ipsen, Tercica received cash proceeds of $6.9 million from share issuance to Genentech and Ipsen in the third quarter.
* With the receipt of the cash proceeds associated with the sale of equity and the $15 million convertible note, Tercica finished the quarter with $127.7 million in cash. Tercica now expects to end 2007 with approximately $110 million in cash.
* Tercica affirmed its expectation that 2007 Increlex® revenues will total approximately $9-10 million.
Conference Call and Webcast Information
Tercica’s senior management team will review third quarter financial results via a conference call and webcast today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time). To access the live teleconference, please dial 888-803-8296 (U.S.) or 706-634-1250 (international), and reference the conference ID# 20286721. To access the webcast, please go to the Events page on the Investors section of the Company’s Web site at www.tercica.com.
A telephone replay will be available approximately two hours after the call for 48 hours by dialing (800) 642-1687 from the U.S., or (706) 645-9291 for international callers, and entering reservation number 20286721. A replay of the webcast will be available on the Company’s Web site for 21 days at www.tercica.com.
About Tercica
Tercica is a biopharmaceutical company committed to improving endocrine health by partnering with the endocrine community to develop and commercialize new therapeutics for pediatric and adult growth disorders, and for adult metabolic disorders. For further information on Tercica, please visit www.tercica.com.
Safe Harbor Statement
Except for the historical statements contained herein, this press release contains forward-looking statements concerning the Company's prospects and expectations, including without limitation, that the Company expects to end 2007 with approximately $110 million in cash, that 2007 Increlex® revenues will be $9-10 million, and that Somatuline® Depot will soon be available for commercial use in the United States. Because Tercica's forward-looking statements are subject to risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, risks and uncertainties related to the following: (i) there may be significant unexpected expenditures; and (ii) sales of Increlex® may be less than expected due to physician discretion or adverse events; and (iii) the FDA may hold the first shipments of Somatuline® Depot pending their inspection; and (iv) the risks and uncertainties disclosed from time- to-time in reports filed by Tercica, including most recently Tercica's Form 10-Q for the quarter ending June 30, 2007 filed with the SEC on August 2, 2007. Tercica disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
TERCICA, INC.
(In thousands, except per share data)
(Unaudited)
Statements of Operations
Three Months Ended September 30,
Nine Months Ended September 30,
2007 2006 2007 2006
Net revenues
Net product sales $ 2,851 $ 316 $ 5,990 $ 567
License revenue 20,537 — 20,925 —
Total net revenues 23,388 316 26,915 567
Costs and expenses:
Cost of sales 2,096 516 4,248 1,156
Research and development(a)
5,588 3,513 14,601 12,739
Selling, general and administrative(a)
11,409 10,162 31,562 31,252
Total costs and expenses 19,093 14,191 50,411 45,147
Income (loss) from operations 4,295 (13,875 ) (23,496 ) (44,580 )
Interest expense 334 — 712 —
Interest and other income, net 1,429 812 4,397 2,564
Other expense 951 — 951 —
Income (loss) before income taxes 4,439 (13,063 ) (20,762 ) (42,016 )
Provision for income taxes 1,017 — 1,017 —
Net income (loss) $ 3,422 $ (13,063 ) $ (21,779 ) $ (42,016 )
Basic net gain (loss) per share $ 0.07 $ (0.35 ) $ (0.43 ) $ (1.14 )
Shares used to compute basic net gain (loss) per share 51,041 37,550 50,458 36,906
Diluted net gain (loss) per share $ 0.07 $ (0.35 ) $ (0.43 ) $ (1.14 )
Shares used to compute diluted net gain (loss) per share 51,345 37,550 50,458 36,906
(a) Includes non-cash stock-based compensation expense as follows:
Research and development $ 405 $ 525 $ 1,454 $ 1,502
Selling, general and administrative 1,086 1,027 3,173 2,814
Total $ 1,491 $ 1,552 $ 4,627 $ 4,316
September 30, December 31,
2007 2006
Balance Sheet Data
Cash, cash equivalents and short-term investments $ 127,749 $ 125,575
Restricted short-term investments 340 340
Total assets 189,072 137,687
Total liabilities
108,918 47,756
Total stockholders’ equity 80,154 89,931
Investor and Media Contact:
Tercica, Inc.
Fredrik Wiklund
Senior Director, Investor Relations &
Corporate Development
650-624-4992
fredrik.wiklund@tercica.com
Source: Business Wire (November 1, 2007 - 4:19 PM EDT)
News by QuoteMedia
www.quotemedia.com
surf1944
17年前
Somatuline(R) Depot Receives FDA Marketing Approval for the Treatment of Acromegaly
Tercica Management Will Hold a Conference Call on August 31st at 9:00 a.m. EDT/ 6:00 a.m. PDT
Tercica, Inc. (NASDAQ:TRCA) today announced that its partner Ipsen (Euronext:IPN) has received notice of approval from the U.S. Food and Drug Administration (FDA) for marketing Somatuline® Depot (lanreotide) injection 60, 90 and 120 mg/ml in the United States.
Somatuline® Depot is indicated for the long-term treatment of acromegaly in patients who have had an inadequate response to surgery and/or radiotherapy, or for whom surgery and/or radiotherapy is not an option. Somatuline® Depot will be available in a pre-filled syringe eliminating any need for reconstitution and thus enabling freedom of easy administration to patients. The FDA has also designated Somatuline® Depot as an orphan drug for acromegaly. The Orphan Drug Act provides a seven-year period of exclusive marketing to the first manufacturer who obtains marketing approval for a designated orphan product.
In October 2006, Ipsen granted to Tercica the development and commercialization rights for Somatuline® Depot in the United States and Canada. At the same time, Ipsen acquired a 25% stake in Tercica on a non-diluted basis. According to the terms of the agreement, the FDA approval of Somatuline® Depot triggers a €30 million (approximately $41 million) milestone payment that Tercica will pay to Ipsen by issuing a convertible bond (converted into Tercica common stock at a conversion price of €5.92). Tercica will simultaneously issue an additional $15 million convertible bond to Ipsen (converted into Tercica common stock at a conversion price of $7.41), which will be paid in cash to Tercica.
“We are delighted with the approval of Somatuline Depot. Somatuline Depot is the only long-acting acromegaly therapy available in a pre-filled syringe, and the only long-acting somatostatin analogue that does not require reconstitution prior to injection. Somatuline Depot provides a significant medical advance for the treatment of acromegaly by offering physicians, nurses, and patients the freedom of easy injections and ready-to-go simplicity. We expect to launch Somatuline Depot in the U.S. in approximately eight weeks,” said John A. Scarlett, M.D., Tercica’s President and Chief Executive Officer. “The approval of Somatuline Depot represents a major step in our goal of establishing Tercica as the leading U.S. endocrine and metabolic company. This will be the second market introduction of an important endocrine product made by Tercica within a two-year period. Tercica has now become a well balanced biotechnology company with two commercial products and an exciting pipeline that includes our next generation growth hormone products targeting existing billion dollar market opportunities,” added Dr. Scarlett.
About Acromegaly
Acromegaly is a disorder caused by the over-production of growth hormone usually by a benign tumor of the anterior pituitary gland. Acromegaly occurs in approximately 60 people per million of population. In acromegaly patients, the pituitary gland releases too much growth hormone into the bloodstream, the growth hormone then triggers the liver to produce IGF-1, which in turn directly stimulates bone and tissue growth. The most common signs and symptoms of this serious condition include: enlarged hands, feet, and head; facial changes such as bulging forehead, enlarged lower jaw, tongue and lips; wider spacing between teeth; enlarged heart, liver, kidneys, spleen and other organs; joint pain and fatigue; reduced sex drive; and loss of concentration.
About the Marketing Approval
This decision follows the filing by Ipsen of a New Drug Application (NDA) for Somatuline® Depot in the United States in December 2006. The effect of Somatuline® Depot on reducing growth hormone and IGF-levels and control of symptoms in patients with acromegaly was studied in two long-term, multiple-dose, randomized multicenter studies performed in the United States and in Europe. Somatuline® Depot demonstrated its ability to decrease the levels of growth hormone and IGF-1 in the majority of patients over a one-year period.
About Somatuline® Depot
Somatuline® Depot (also marketed as Somatuline® Autogel® outside the United States) is a sustained-release formulation for injection containing lanreotide, a somatostatin analogue (a hormone that inhibits the release of growth hormone). Somatuline® Depot was initially developed and continues to be used mainly in the treatment of acromegaly, a disorder caused by the over-production of growth hormone or prolactin due to a benign tumor of the anterior pituitary gland. This product subsequently underwent further development in Europe in the treatment of symptoms associated with neuroendocrine tumors (particularly of a carcinoid type). Ipsen believes that the Somatuline® Depot formulation, to which it holds the patent, represents a major technological advance. As far as Ipsen is aware, this represents the first semi-solid formulation for injection without any excipient, since the active substance itself controls the sustained release. Somatuline® Depot releases the active substance with no excipient other than water over a period of at least 28 days, thus requiring just one injection per month, compared with the two or three injections previously necessary. This product is presented in a pre-filled syringe for easier administration.
Active Substance
The active substance in Somatuline® Depot is lanreotide, which inhibits the growth and secretion of several endocrine, exocrine and paracrine functions. It is particularly effective in inhibiting the secretion of growth hormone.
Indications
Somatuline® Depot is indicated for the treatment of acromegaly when circulating levels of growth hormone remain high despite surgery or radiotherapy. Somatuline® inhibits growth hormone release and thus controls the therapeutic and relieves the symptoms associated with elevated levels of this hormone.
surf1944
17年前
Tercica Announces Agreement with Genentech for Worldwide Growth Hormone and IGF-1 Combination Product Development and Commercialization
Combination Products for the Potential Treatment of Short Stature and Adult Growth Hormone Deficiency
Tercica May Receive up to $53 Million in Equity Payments, Opt-in Payments, R&D Reimbursement and Milestone Payments from Genentech
Pending FDA guidance, Tercica intends to initiate Phase II Clinical Trials in 2008
Tercica, Inc. (Nasdaq:TRCA) today announced an agreement with Genentech, Inc. for the development, manufacture and worldwide commercialization of two products containing Genentech’s recombinant human growth hormone Nutropin AQ® [somatropin (rDNA origin)] and Tercica’s recombinant insulin-like growth factor-1 Increlex® (mecasermin [rDNA origin] injection) for the treatment of short stature, adult growth hormone deficiency (AGHD), and potentially other metabolic disorders. Nutropin AQ® and Increlex® were originally designed and formulated so that the therapies could be combined and potentially given as a single, daily injection.
Pending U.S. Food and Drug Administration guidance and timely IND acceptance, Tercica plans to initiate Phase II clinical development in 2008 of one combination product for patients with low IGF-1 levels and short stature not associated with growth hormone deficiency; and a second combination product for patients with AGHD.
“This collaboration allows us to embark on two new and exciting development programs that each have scientific merit,” said John A. Scarlett, M.D., Tercica’s President and Chief Executive Officer. “With demonstrated synergies in pre-clinical studies, the combination of rhGH and rhIGF-1 could have the potential for several important therapeutic benefits compared to either rhGH or rhIGF-1 monotherapy alone for the treatment of patients with short stature and AGHD and potentially other adult metabolic disorders. With our current cash position, equity sales associated with this agreement and possible collaboration for both programs through sublicensing of Tercica’s ex-U.S. rights, Tercica continues to have profitability in 2010 as a goal without additional equity financing unless needed to support additional new initiatives or strategic opportunities.”
Terms of Agreement
Under the terms of the collaboration, Tercica may be eligible to receive a total of up to $53 million in equity payments, opt-in payments, research and development cost reimbursement, and milestone payments. In connection with the transaction, Genentech will purchase 708,591 shares of Tercica’s common stock for $4 million.
Tercica will fund and lead initial development efforts for both combination products. Genentech has certain rights to opt-in to the development programs for both products. The opt-in rights remain open until completion of a Phase II clinical study for each product that is sufficient to enable a pivotal trial.
Upon exercise of any opt-in by Genentech, Genentech shall reimburse certain incurred research and development costs. Following such exercise by Genentech, a cost and profit share structure will take effect for all future development and commercial activities of both combination products, and Genentech will have certain commercialization rights, including the right to co-promote both combination products upon regulatory approval. If Genentech does not exercise any of its opt-in rights, then Tercica will have full development and commercialization rights to the combination products, and will owe Genentech royalties on worldwide sales.
Development of GH/IGF-1 Combination Product
About Increlex®(mecasermin [rDNA origin] injection): The active ingredient of Increlex® is recombinant human insulin-like growth factor-1 (IGF-1). IGF-1 is the direct mediator of growth hormone's (GH) effect on statural growth, and must be present for normal growth of bones and cartilage in children. In Primary IGFD, children's serum IGF-1 levels are low, despite the presence of a normal or elevated GH level. Without adequate IGF-1, children cannot achieve normal height. In children with this disorder, low IGF-1 levels are due to growth hormone resistance associated with mutations in GH receptors, post-GH receptor signaling pathways, or to defects in IGF-1 gene expression. Increlex® has been marketed in the United States by Tercica since early 2006. Exclusive rights to develop and commercialize Increlex® were licensed to Ipsen in October 2006 for all regions of the world except the United States, Japan, Canada, Taiwan and certain countries of the Middle East and North Africa.
About Nutropin AQ® [somatropin (rDNA origin)]: Nutropin AQ® [somatropin (rDNA origin) injection] is produced using recombinant DNA technology and has the same amino acid sequence as human growth hormone produced naturally in the human body. It is marketed as Nutropin AQ® in Austria, Denmark, Finland, France, Germany, Ireland, the Netherlands, Norway, Sweden, Portugal, Spain and the United Kingdom. Other regulatory reviews are underway in Europe and worldwide, excluding North America and Japan.
Nutropin AQ® is supplied as 10 mg of sterile liquid somatropin per cartridge for exclusive use with the Nutropin AQ® Pen, a simple, convenient, easy-to-use device for subcutaneous injection. Nutropin AQ® is approved for the treatment of GHD in children and adults, for the long-term treatment of short stature in children with Turner syndrome, the treatment of growth failure in chronic renal insufficiency patients prior to transplantation and the long-term treatment of children with idiopathic (of unknown origin) short stature (ISS).
Potential of GH/IGF-1 Combination Product for Short Stature: One combination product will initially be studied in patients with low IGF-1 levels and short stature not associated with growth hormone deficiency, for example ISS. A potential cause of short stature in this group of patients could be a suboptimal IGF-1 secretion in response to growth hormone stimulation alone. Pre-clinical studies suggest that co-administration of GH and IGF-1 may increase specific growth responses greater than either therapy alone. Therefore, Tercica believes that treatment with a combination of both GH and IGF-1 may be superior to monotherapy of either component alone in a subpopulation of children with low IGF-1 and short stature not associated with growth hormone deficiency.
Potential of GH/IGF-1 Combination Product for AGHD: A second combination product will initially be studied in the AGHD population. These patients have abnormalities in body composition (e.g., increased body fat and reduced lean muscle mass). Preclinical studies have suggested that co-administration of GH and IGF-1 result in synergistic effects on these parameters. Tercica also believes that delivered together as a combination product, some of the negative effects of each individual component could potentially be mitigated by the positive effects of the other, especially their effects on glucose metabolism. Upon review of the clinical data in AGHD, Tercica and Genentech will evaluate the attractiveness of this combination product in treating other metabolic disorders.
Conference Call and Webcast Information
Tercica’s senior management team will host an investment community conference call tomorrow to discuss the collaboration with Genentech beginning at 9:00 a.m. EDT. To access the live teleconference, please dial (888) 803-8296 (U.S.) or (706) 634-1250 (international) and reference the conference ID# 6557103. To access the webcast, please go to the Events page on the Investors section of the Company’s Web site at www.tercica.com.
A telephone replay will be available approximately two hours after the call for 48 hours by dialing (800) 642-1687 from the U.S., or (706) 645-9291 for international callers and entering reservation number 6557103. A replay of the webcast will be available on the Company’s Web site for 21 days at www.tercica.com.
About Tercica
Tercica is a biopharmaceutical company committed to improving endocrine health by partnering with the endocrine community to develop and commercialize new therapeutics for short stature and other metabolic disorders. For further information on Tercica, please visit www.tercica.com.
Safe Harbor Statement
Except for the historical statements contained herein, this press release contains forward-looking statements concerning Tercica’s prospects and expectations, including without limitation, that Tercica: (A) may receive from Genentech up to $53 million in equity, opt-in and milestone payments and research and development cost reimbursement; (B) plans to initiate Phase II clinical development of the combination products in 2008 for both short stature and AGHD; (C) believes that treatment with a combination of both GH and IGF-1 may offer several important therapeutic benefits when compared with, and be superior to monotherapy in a subpopulation of children with low IGF-1 and short stature not associated with growth hormone deficiency, and for patients with AGHD; (D) believes that for patients with AGHD, delivered together as a combination product, some of the negative effects of each individual component could potentially be mitigated by the positive effects of the other, especially their effects on glucose metabolism; and (E) continues to have profitability as a goal in 2010 without the need for additional equity financing. Because Tercica's forward-looking statements are subject to risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include, without limitation, risks and uncertainties related to the following: (i) for (A) (C) (D) and (E) above, data from Tercica’s clinical trials of the combination products may not demonstrate sufficient efficacy or safety for either clinical development or commercial purposes or to enable Tercica to receive any financial remuneration, and Genentech may never opt-in; (ii) for (B) above, the FDA may have concerns or requirements that impede Tercica from beginning the Phase II clinical trials in 2008 or cause Tercica to stop all clinical development of the combination products; (iii) also for (E) above, Tercica’s internal projections for revenues and costs through 2010 may be incorrect or not actually achieved, Tercica may be unable to sublicense its ex-U.S. rights on financial terms that it projects, or at all, and Tercica may undertake new and costly initiatives or strategic opportunities; and (iv) for (A) – (E) above, the risks and uncertainties of drug development and others risks and uncertainties disclosed from time-to-time in reports filed by Tercica, including most recently Tercica's Form 10-Q for the quarter ending March 31, 2007 filed with the SEC on May 4, 2007. Tercica disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.
Tercica, Inc.
Fredrik Wiklund
Senior Director, Investor Relations &
Corporate Development
650-624-4992
fredrik.wiklund@tercica.com
Source: Business Wire (July 10, 2007 - 4:05 PM EDT)
coinstarz
19年前
Tercica Reports Fourth Quarter Financial Results; Conference Call Begins at 4:30 p.m. Eastern Time Today
Business Wire - February 15, 2006 16:01
BRISBANE, Calif., Feb 15, 2006 (BUSINESS WIRE) -- Tercica, Inc. (Nasdaq:TRCA) today announced financial and operating results for the fourth quarter and year ended December 31, 2005.
Financial Results
The net loss for the fourth quarter was $14.4 million, or $0.46 per share based on 31.5 million weighted-average shares outstanding, compared with a net loss of $11.2 million, or $0.46 per share based on 24.1 million weighted-average shares outstanding, for the fourth quarter of 2004.
Research and development expenses for the fourth quarter decreased to $4.7 million from $7.6 million for the prior year fourth quarter, due primarily to reduced GMP manufacturing activities that were required to support our NDA filing in early 2005.
Selling, general and administrative expenses for the fourth quarter were $8.9 million, up from $3.8 million for the comparable prior-year period, reflecting higher intellectual property litigation expense and pre-launch commercial activities for Increlex(TM).
Other expense for the quarter of $1.3 million consisted primarily of the non-cash charge related to the value of the warrants issued in connection with the Committed Equity Financing Facility with Kingsbridge Capital, which was expensed in the fourth quarter of 2005.
For the year, Tercica reported a net loss of $47.4 million, or $1.55 per share based on 30.6 million weighted-average shares outstanding, compared with a net loss of $41.0 million, or $2.12 per share based on 19.3 million weighted-average shares outstanding, for 2004.
Cash, cash equivalents and short-term investments as of December 31, 2005 were $58.6 million, compared with $52.0 million as of December 31, 2004. Tercica raised $34.5 million in gross proceeds from a financing completed in January 2006, which is not reflected on the 2005 year-end balance sheet.
"Our commercial team is diligently focused on the U.S. launch of Increlex, the only drug approved by the FDA for the long-term treatment of growth failure in children with severe Primary IGF-1 deficiency. I am delighted to report that we are successfully implementing our launch strategy, and that we achieved all our commercial objectives during the fourth quarter including commercial staffing, patient advocacy and reimbursement. Importantly, we began shipping Increlex on January 3, 2006, right on plan," said John A. Scarlett, M.D., Tercica's President and Chief Executive Officer.
Highlights of the fourth quarter and recent developments include:
-- Completion of the manufacturing, distribution and commercial operations requirements necessary to launch Increlex (mecasermin (rDNA origin) injection) in the U.S. on January 3, 2006 for the treatment of children afflicted with severe Primary IGFD.
-- Completion of the build out of the commercial organization, which now includes 24 sales representatives, three regional business directors and three national account executives.
-- Implementation of the TerciCare reimbursement support team, which facilitates the information exchange between patients, healthcare providers and health insurance companies to help patients gain appropriate reimbursement coverage for Increlex.
-- Submission of a marketing application in December 2005 for the regulatory approval of Increlex in the European Union (EU), with an expected commercial launch in January 2007; Tercica estimates that the number of children with severe Primary IGFD in the EU is approximately equal to that in the U.S.
-- Completion of a public offering of common stock in January 2006, raising gross proceeds of $34.5 million.
2006 Financial Guidance
The Company also announced that it expects cash burn in 2006, including working capital requirements and excluding the impact of revenue and related product costs, to be in the range of $63 million to $69 million. Tercica will provide revenue guidance upon assessment of two quarters of product sales.
Conference Call and Webcast Information
Management will be hosting an investment community conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss fourth quarter financial results, provide a business update including a discussion of enrollment and conduct of the MS301 and MS308 clinical trials, and to answer questions. To participate by telephone, please dial (888) 803-8296 from the U.S., or (706) 634-1250 from outside the U.S.
A telephone replay of the conference call will be available for 48 hours beginning February 15 within two hours of the conclusion of the call, by dialing (800) 642-1687 from the U.S., or (706) 645-9291 for international callers, and entering reservation number 4706336. Individuals interested in listening to the conference call via the Internet may do so by visiting www.tercica.com. A replay will be available on the Company's Web site for 21 days.
About Tercica and Increlex
Tercica, Inc. is a biopharmaceutical company focused on the development and commercialization of products to improve endocrine health. The company's first product, Increlex (mecasermin (rDNA origin) injection), or recombinant human insulin-like growth factor-1 (rhIGF-1), is approved by the FDA for the treatment of severe Primary IGFD. For further information on Tercica, please visit www.tercica.com.
Insulin-like Growth Factor-1 (IGF-1) is the principal hormone necessary for statural growth, and is released in response to stimulation by growth hormone. Primary IGFD is diagnosed in children who have normal or elevated secretion of endogenous growth hormone yet are resistant to its effects, and whose height and serum IGF-1 levels are more than two standard deviations below normal. A sub-set of these children, whose height and serum IGF-1 levels are more than three standard deviations below normal, are diagnosed with severe Primary IGFD.
Safe Harbor statement
Except for the historical statements contained herein, this press release contains forward-looking statements, including without limitation the statements that the Company: (1) estimates that the severe Primary IGFD population in the EU is approximately equal to that in the U.S.; and (2) expects that cash burn in 2006, including working capital requirements and excluding the impact of revenue and related product costs, is expected to be in the range of $63 million to $69 million. Because Tercica's forward-looking statements are subject to risks and uncertainties, there are important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include without limitation those risks and uncertainties disclosed from time to time in periodic reports filed by Tercica with the SEC, in Tercica's Form 424(B5) filed on January 24, 2006; and with respect to (1) above, there may be fewer children than Tercica estimates; and with respect to (2) above, the Company may spend more for clinical trials, new development projects, litigation, or for other reasons. These statements are based on information as of February 15, 2006, and the Company assumes no obligation to update any forward-looking statement.
TERCICA, INC.
(A DEVELOPMENT-STAGE COMPANY)
(In thousands, except per share data)
(Unaudited)
Three Months Ended Year Ended
Statements of Operations December 31, December 31,
------------------- -------------------
2005 2004 2005 2004
--------- --------- --------- ---------
Costs and expenses:
Research and development(a) $4,716 $7,646 $21,587 $27,918
Selling, general and
administrative(a) 8,882 3,795 25,913 12,552
Acquired in-process
research and development -- -- -- 1,417
--------- --------- --------- ---------
Total costs and expenses (13,598) (11,441) (47,500) (41,887)
Interest expense (181) -- (1,080) --
Interest income 651 252 2,427 885
Other expense, net (1,274) -- (1,276) --
--------- --------- --------- ---------
Net loss $(14,402) $(11,189) $(47,429) $(41,002)
========= ========= ========= =========
Basic and diluted net loss per
share $(0.46) $(0.46) $(1.55) $(2.12)
========= ========= ========= =========
Shares used to compute basic
and diluted net loss per share 31,534 24,064 30,590 19,302
========= ========= ========= =========
-------------------------------
(a) Includes non-cash
stock-based compensation
expense as follows:
Research and development $253 $291 $1,188 $1,386
Selling, general and
Administrative 198 379 1,006 1,455
--------- --------- --------- ---------
Total $451 $670 $2,194 $2,841
========= ========= ========= =========
December 31, December 31,
2005 2004
------------ ------------
(1)
Balance Sheet Data
Cash, cash equivalents and
short-term investments $58,626 $52,001
Total assets 66,316 55,022
Total liabilities 9,518 7,345
Total stockholders' equity 56,798 47,677
(1) Derived from the audited financial statements for the year ended
December 31, 2004 included in the Company's Form 10-K.
SOURCE: Tercica, Inc.
Tercica, Inc.
Investors:
Ina McGuinness, 650-624-4949
ina.mcguinness@tercica.com
or
Media:
Kathleen Rinehart, 650-624-4948
kathleen.rinehart@tercica.com
coinstarz
19年前
Tercica Announces $30 Million Financing
Business Wire - January 24, 2006 09:47
BRISBANE, Calif., Jan 24, 2006 (BUSINESS WIRE) -- Tercica, Inc. (NASDAQ:TRCA) announced today that it is selling 5,000,000 shares of its common stock pursuant to an effective shelf registration statement. Tercica expects the net proceeds from the sale of the shares to be approximately $30 million, after deducting underwriting discounts and commissions, but before the expenses of the offering. Tercica also granted to the underwriter a 30-day option to purchase up to an additional 750,000 shares of common stock. All of the shares in the offering are being sold by Tercica. Lehman Brothers Inc. is acting as sole underwriter for the offering. Tercica expects the closing of the offering to occur on or about January 27, 2006.
A registration statement relating to these securities has been filed with and declared effective by the Securities and Exchange Commission. Additional information and details with respect to the offering will be included in a final prospectus supplement and related prospectus that will be filed with the Securities and Exchange Commission prior to closing. When available, the final prospectus supplement and the related prospectus may be obtained from Lehman Brothers Inc., c/o ADP Financial Services, Integrated Distribution Services, 1155 Long Island Avenue, Edgewood, NY 11717, 631-254-7106.
This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, any of the securities, nor shall there be any sale of these securities, in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
About Tercica
Tercica, Inc. is a biopharmaceutical company focused on the development and commercialization of products to improve endocrine health. Tercica's first product, Increlex(TM), or recombinant human insulin-like growth factor-1 (rhIGF-1) is approved by the FDA for the long-term treatment growth failure due to severe Primary IGFD. For further information on Tercica, please visit www.tercica.com.
Safe Harbor Statement
This press release contains "forward-looking statements." For this purpose, any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements, including, without limitation, statements regarding Tercica's plans to complete a public offering. Words such as "believes," "anticipates," "plans," "expects," "will," "intends" and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Tercica's results to differ materially from those indicated by these forward-looking statements, including without limitation, risks and uncertainties related to satisfaction of customary closing conditions related to the public offering. There can be no assurance that Tercica will complete the offering of the common stock on the anticipated terms, or at all. In addition, Tercica's business is subject to the risks detailed in Tercica's filings with the Securities and Exchange Commission, including the preliminary prospectus supplement and related prospectus with respect to the offering filed on January 24, 2006. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Tercica undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.
SOURCE: Tercica, Inc.
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